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Adverse_Drug_Reaction_News_Headlines.csv
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Date,Source,Headlines,Teaser
February 2008 ,Medscape Medical News,Adverse Event Reporting for Cancer Therapy Needs Revision,"The Common Terminology Criteria for Adverse Events was developed to standardize language for reporting adverse events that occur in NCI-sponsored clinical trials, but it is unable to adequately code the subacute adverse events that occur with new targeted therapies."
February 2008 ,Medscape Medical News,"Respiratory Compromise, Death May Be Linked to Botulinum Toxin","An ongoing FDA safety review of Botox, Botox Cosmetic (botulinum toxin type A), and Myobloc (botulinum toxin type B) has shown systemic adverse reactions resembling botulism."
February 2008 ,Medscape Medical News,FDA Takes Action to Stop Marketing of Unapproved Colchicine Injection,"The US Food and Drug Administration has received 50 reports of adverse events with colchicine injection, including 23 deaths, related to product use."
February 2008 ,Medscape Medical News,Two Studies Describe Approaches Shown to Reduce Obstetrical Errors,Yale teaching hospital cut its obstetrical error rate in half after implementing changes; a single change by a Pennsylvania hospital also showed improvement in patient safety.
February 2008 ,Medscape Medical News,Varenicline May Be Linked to Risk for Serious Symptoms,"Patients given varenicline should be monitored for strange thoughts/behaviors, depressed mood, and suicidality."
February 2008 ,Medscape Medical News,Antiepileptic Drugs Linked to Increased Risk for Suicidality,Patients taking certain drugs for epilepsy or other indications should be carefully monitored for behavioral changes.
January 2008 ,Medscape Medical News,Heparin Recall,Nine lots of the antithrombin have been recalled because of a higher-than-expected rate of allergic reactions.
September 2007 ,Medscape Medical News,Adverse Drug Events More Than Doubled Between 1998 and 2005,Serious adverse drug events reported to the US Food and Drug Administration's Adverse Event Reporting System increased 4 times faster than did the total number of outpatient prescriptions during this period.
June 2007 ,Medscape Medical News,CF Patient Death May be Linked to Colistimethate Inhalation Therapy,"Inhalation solution should be used immediately to reduce the risk for pulmonary toxicity, according to the FDA."
May 2005 ,Medscape Medical News,Isotretinoin May Decrease Depression in Adolescents With Acne,"Treatment of moderate-severe acne either with conservative therapy or with isotretinoin was associated with a decrease, not an increase, in depressive symptoms."
January 2005 ,Medscape Medical News,"FDA Safety Labeling Changes: Vesanoid, Kaletra, Axid, Enbrel","The FDA has approved revisions to the safety labeling for tretinoin capsules (Vesanoid), lopinavir/ritonavir capsules and oral solution (Kaletra), nizatidine 75-mg tablets (Axid AR), and etanercept (Enbrel)."
January 2005 ,Medscape Medical News,"Clozapine, Olanzapine May Increase Risk of Insulin Resistance","A cross sectional study suggests that compared with risperidone, use of these drugs is associated with a significantly higher risk of developing insulin resistance."
July 2002 ,Medscape Medical News,Beta-Blockers May Be Underused,"No increase in depression risk was seen, but there was a small risk of fatigue and sexual dysfunction."
June 2000 ,Medscape Medical News,Estrogen Replacement May Negate the Benefits of Growth Hormone,"In a preliminary study, researchers have found evidence that boosting production of growth hormone can reduce body fat and help maintain levels of functioning in elderly men and women."
April 2008 ,Medscape Medical News,Rotigotine Patch Recalled Due to Drug Crystallization,Drug crystallization can hamper absorption; healthcare professionals are advised to begin down-titrating patients according to product guidelines and should not initiate rotigotine therapy in new patients.
April 2008 ,Medscape Medical News,Rubber Chemical Found in Daptomycin Infusion Pumps,Healthcare professionals are advised to avoid the use of daptomycin with ReadyMED elastomeric infusion pumps.
April 2008 ,Medscape Medical News,Exubera Gets Lung Cancer Warning,Cases occurred in prior smokers and are too few to establish a causal role for the product.
April 2008 ,Medscape Medical News,Transparency in Adverse Event Reporting Pleases Patients,A new survey reveals that hospitalized patients are informed of less than half of all adverse events that they experience.
April 2008 ,Medscape Medical News,Tegaserod Maleate Restricted to Emergency Use Only,FDA must approve requests for tegaserod maleate and must authorize shipments from the manufacturer.
March 2008 ,Medscape Medical News,Study Data Link 2 NRTIs to Increased MI Risk,"The FDA recommends that healthcare professionals discuss potential risks and benefits of abacavir (Ziagen) and didanosine (Videx) therapy, including myocardial infarction, with HIV-infected patients."
March 2008 ,Medscape Medical News,Diabetic Ulcer Gel Linked to Increased Cancer Deaths,Healthcare professionals are advised to discuss risks and benefits of becaplermin gel (Regranex) with patients.
March 2008 ,Medscape Medical News,"Asthma Medication Evaluated for Possible Link to Mood Changes, Suicidality",The FDA has issued a MedWatch Safety alert informing doctors and patients that it is investigating a possible link between use of montelukast and changes in mood and behavior as well as suicidality and suicide.
March 2008 ,Heartwire from Medscape,More Heparin Recalls in Europe and US,"The latest countries to recall heparin products are France, Italy, and Denmark, and the affected material has been traced to four Chinese suppliers. Another US manufacturer has also recalled some heparin products."
March 2008 ,Heartwire from Medscape,Heparin Contaminant Identified,The contaminant found in samples of heparin that had been linked to an increase in adverse reactions has now been identified as oversulfated chondroitin sulfate.
March 2008 ,Medscape Medical News,Tiotropium Linked to Possible Increased Risk of Stroke,"On the basis of an ongoing safety review, MedWatch reports a possible increased risk of stroke with use of tiotropium."
March 2008 ,Medscape Medical News,Serious Skin Reactions Reported With TNF-alpha Antagonists,"Safety reviews of infliximab, etanercept, and adalimumab identified rare cases of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and other skin reactions."
March 2008 ,Medscape Medical News,Black Box Warning Issued for Etanercept Regarding Infections,A black box warning to be included on etanercept's prescribing information states that tuberculosis has been observed with TNF-blocking agents and that tuberculosis may be caused by reactivation of latent tuberculosis infection and by new infection.
March 2008 ,Heartwire from Medscape,Heparin Contaminant Traced to China,The FDA has also issued an import alert requiring all heparin products be tested for the contaminant.
March 2008 ,Medscape Medical News,New HIV Drug Linked to Risk for Hepatitis,Liver enzymes should be monitored during treatment with ritonavir-boosted darunavir.
March 2008 ,Medscape Medical News,Cough Medicine Dosing Errors Linked to Patient Deaths,Patients should not take hydrocodone plus chlorpheniramine extended-release suspension (Tussionex) more often or at higher doses than recommended.
March 2008 ,Heartwire from Medscape,Heparin Contaminant,"The FDA is requesting all heparin manufacturers to test products for this contaminant. Increased rates of adverse reactions have now also been reported in Germany with heparin not made by Baxter or its supplier, Scientific Protein Laboratories."
March 2008 ,Medscape Medical News,What Your Patients Are Reading,"Hormone replacement therapy may result in a higher risk for breast cancer, both hysterectomy and uterine artery embolization can help treat uterine fibroids, tendonitis may be a result of statin use, obese children have more surgical complications than children of a normal weight, a change in selective serotonin reuptake inhibitors in conjunction with cognitive behavioral therapy may be adequate t"
March 2008 ,Medscape Medical News,Antiviral Drug Labels Get Warnings for Neuropsychiatric Changes,Patients with influenza should be closely monitored for signs of abnormal behavior during treatment with Tamiflu and possibly also Relenza.
February 2008 ,Medscape Medical News,Natalizumab May Cause Significant Liver Injury,Natalizumab (Tysabri) should be discontinued in patients with jaundice or other signs of liver injury.
August 2008 ,Medscape Medical News,Byetta Linked to Acute Pancreatitis,Exenatide therapy has been linked to 6 new cases of hemorrhagic or necrotizing pancreatitis.
August 2008 ,Medscape Medical News,FDA Warns About Injection Site Reactions With Naltrexone,"Injectable, extended-release naltrexone, used for the treatment of alcohol dependence, has been linked to adverse injection-site reactions, some requiring surgery."
August 2008 ,Medscape Medical News,"HPV Vaccine Deemed Safe and Effective, Despite Reports of Adverse Events","Questions over the safety of the human papillomavirus vaccine have been raised by consumers, parents, healthcare professionals, and others. But having analyzed the available data, the CDC and FDA offer reassurance."
August 2008 ,Medscape Medical News,FDA Releases List of Genomic Biomarkers Predictive of Drug Interactions,Quarterly updates of the table by the US Food and Drug Administration should help keep clinicians and patients informed about potential drug response and risk for adverse reactions.
July 2008 ,Medscape Medical News,Genetic Screening Recommended Before Abacavir HIV Therapy,Screening for a particular allele can decrease the risk for abacavir hypersensitivity reactions by 60%.
July 2008 ,Medscape Medical News,"Herceptin Vials to Be Checked for Damage, FDA Warns",Breakage and other damage may compromise sterility and pose infection risk to patient.
July 2008 ,Medscape Medical News,"FDA Advisory Members Agree AEDs Pose Suicidality Risk, Nix Black Box","Antiepileptic drugs pose an increased risk of suicidality, but the data do not warrant a black-box warning, advisory committee members told the FDA."
July 2008 ,Medscape Medical News,Fluoroquinolones Earn Black Box Warning for Tendon-Related Adverse Effects,The magnitude of reported adverse events related to fluoroquinolone use necessitates stronger warnings regarding the risk for tendonitis and tendon rupture.
July 2008 ,Medscape Medical News,Local and National Legislation Banning Phthalates and BPA Considered,A bill has been introduced to Congress to prohibit the use of bisphenol A in all food and drink containers; the Senate is considering expanding the proposed ban to include toys and other children's products.
July 2008 ,Medscape Medical News,Use of rhBMP in Cervical Fusion Linked to Serious Adverse Events,Healthcare providers should use approved alternative treatments or enroll in approved clinical trials.
July 2008 ,Medscape Medical News,CellCept Labeling Changes Reflect PML Risk,Healthcare providers should include progressive multifocal leukoencephalopathy in the differential diagnosis of immunosuppressed patients presenting with focal neurologic symptoms.
June 2008 ,Medscape Medical News,Probe of Erythropoiesis-Stimulating Agents,The preliminary work suggests that erythropoietin might have an effect not only on red blood cells but on tumor blood vessels as well. It is a provocative hypothesis that is generating fervent debate.
June 2008 ,Medscape Medical News,Diabetic Ulcer Gel Gets Black Box Warning,An FDA safety review showed a 5-fold increased risk for cancer mortality in patients exposed to 3 or more tubes of becaplermin gel.
June 2008 ,Heartwire from Medscape,Five Deaths in the UK Related to Rimonabant,"But only one of these deaths was due to psychiatric disorders (suicide), which is the major concern with this drug. Sanofi-Aventis has stressed that no causal link between any of the deaths and rimonabant has been established."
June 2008 ,Medscape Medical News,FDA Investigates Link Between TNF Blockers and Pediatric Cancer,"Thirty cases of cancer have been reported in children and young adults receiving tumor necrosis factor blockers for arthritis, Crohn's disease, and other conditions."
May 2008 ,Medscape Medical News,Transplant Drug Linked to Risk for Fetal Harm,"Women of childbearing age should be required to use 2 forms of birth control before, during, and after treatment with mycophenolate mofetil and mycophenolic acid."
May 2008 ,Heartwire from Medscape,FDA Backpedals on Echo-Contrast Labeling,Warnings and contraindications imposed late last year have been softened after the agency heard from the medical community.
May 2008 ,Medscape Medical News,Etanercept Gets Black Box Warning for TB Risk,Patients should be both screened for latent tuberculosis before initiation of etanercept therapy and monitored for infection during and after treatment.
April 2008 ,Medscape Medical News,Enoxaparin Contaminant,"Some countries have recalled affected batches, although no increase in adverse reactions has been seen."
April 2008 ,Medscape Medical News,Anticholinergic Drugs May Increase Cognitive Decline,A new study finds that use of drugs with anticholinergic activity is associated with a more rapid decline in cognitive performance.
November 2008 ,WebMD Health News,Panel: Toughen Dermal Filler Warnings,An FDA panel wants stronger warning labels on dermal fillers like Restylane and Juvederm injected into the face for wrinkles.
November 2008 ,Medscape Medical News,Bevacizumab Significantly Increases VTE Risk,"The risk of venous thromboembolism was increased by 33%, compared with controls, concludes a new meta-analysis of 15 cancer trials."
November 2008 ,Medscape Medical News,"No Link Between Bisphosphonates and Atrial Fibrillation, FDA Says",The agency is advising healthcare professionals not to alter their prescribing patterns for bisphosphonate therapy.
November 2008 ,Medscape Medical News,Five Generic Ethex Products Recalled Because of Overdose Risk,Oversize tablets may contain up to double the amounts of the active ingredient.
October 2008 ,Medscape Medical News,Rimonabant Suspended in Europe,"European regulators say rimonabant's benefits no longer outweigh its risks. Its manufacturer, however, says it remains committed to the drug and hopes to provide evidence to support its reevaluation in the future."
October 2008 ,Medscape Medical News,Postmarketing Surveillance for Biologic Agents,"Biologics are a rapidly growing class of drugs, but many of their associated safety problems are not identified until after receiving approval from regulatory agencies."
October 2008 ,Medscape Medical News,Boxed Warning Highlights Risk for Infection With Raptiva,Postmarketing reports indicate an increased risk for opportunistic infections in patients receiving efalizumab injection.
October 2008 ,Medscape Medical News,Preliminary Data Suggest Spiriva Not Linked to Increased Stroke Risk,Findings contradict recently published findings that tiotropium bromide increases the risk for mortality and/or cardiovascular events.
September 2008 ,Medscape Medical News,High-Dose Epogen/Procrit Linked to Deaths,Adverse events in other epoetin-alfa clinical trials should be monitored to ensure that the potential benefits outweigh the risks to patients.
September 2008 ,Medscape Medical News,Tarceva Linked to 2 Fatal Cases of Hepatotoxicity,Patients with hepatic impairment should be closely monitored during treatment with erlotinib.
September 2008 ,Medscape Medical News,Particulate Matter Found in Ammonul Injection,Filters must be used during the admixture process because particulate matter may not be visible to the naked eye.
September 2008 ,Medscape Medical News,"Company, Investigator Disagree on Reporting of Epoetin Alfa Trial","Ortho Biotech announced that preliminary data from a trial of epoetin alfa in stroke patients show higher mortality among treated patients than those on placebo and that it had informed the FDA. The lead investigator of the trial, though, says the statement is inaccurate as it stands and that the increase in mortality was limited to patients who received both tissue plasminogen activator and epoet"
September 2008 ,Medscape Medical News,Phosphocol Linked to Risks for Malignancy and Radiation Injury,Postmarketing cases of lymphocytic leukemia have been reported with intra-articular use; intraperintoneal use has been linked to local necrosis and fibrosis.
September 2008 ,Medscape Medical News,Rituxan Linked to Fatal PML Case,Clinicians are advised to consider progressive multifocal leukoencephalopathy in rituximab-treated patients presenting with new-onset neurologic manifestations.
September 2008 ,WebMD Health News,20 Drugs the FDA Is Watching,The first new quarterly report identifies adverse drug effects that are under FDA investigation.
September 2008 ,Medscape Medical News,Patient Deaths Spark Stronger Warnings for TNF Blockers,Patients should be monitored for signs and symptoms of fungal infection both during and after therapy.
August 2008 ,Medscape Medical News,Effects of Sunitinib in Renal Cell Cancer Patients,Researchers describe adverse dermatologic effects in the scrotal and inguinal areas in 5 of 40 patients taking sunitinib for renal cell carcinoma.
August 2008 ,WebMD Health News,"Cialis, Viagra Labels to Note Amnesia",Rare reports of transient global amnesia have been added to the Cialis and Viagra labels; the condition is already on the Levitra label.
August 2008 ,Medscape Medical News,New PML Cases Reported With Tysabri Monotherapy,Natalizumab monotherapy is still believed to be safer than combination treatment with other immunomodulatory agents.
August 2008 ,Medscape Medical News,Taxanes Increase Risk for Psychologic Symptoms,Patients who receive taxane-based chemotherapy have delayed emotional recovery and a higher rate of probable clinical depression than patients on similar regimens without taxanes.
January 2009 ,Medscape Medical News,"FDA Safety Changes: Norditropin, Rozerem, Zomig","The FDA has approved revisions to the safety labeling for somatropin [rDNA origin] injection (Norditropin), ramelteon (Rozerem), and zolmitriptan (Zomig)."
January 2009 ,Medscape Medical News,"FDA Safety Changes: Apidra, Ontak, Raptiva","The FDA has approved revisions to the safety labeling for insulin glulisine [rDNA origin] injection (Apidra), denileukin diftitox (Ontak), and efalizumab (Raptiva)."
December 2008 ,Medscape Medical News,"FDA Safety Changes: Celexa, Erbitux, ACE Inhibitors","The FDA has approved revisions to the safety labeling for citalopram HBr tablets and oral solution, cetuximab intravenous infusion, and certain angiotensin-converting enzyme inhibitors."
January 2009 ,Medscape Medical News,"FDA Safety Changes: Clolar, Precedex, Treanda","The FDA has approved revisions to the safety labeling for clofarabine injection (Clolar), dexmedetomidine HCl injection (Precedex), and bendamustine HCl injection (Treanda)."
January 2009 ,Medscape Medical News,FDA Warns That Tinzaparin Increases Mortality Risk in Elderly Patients,A clinical study indicated that tinzaparin may lead to an increased risk for death in all renal-impaired elderly patients receiving tinzaparin.
December 2008 ,Medscape Medical News,Prolonged Empiric Antibiotics May Increase Risk for NEC in Certain Infants,"In extremely-low-birth-weight infants, prolonged initial empiric antibiotics should be used with caution because they may be associated with an increased risk for necrotizing enterocolitis or death."
December 2008 ,Medscape Medical News,AES 2008: Valproate Should Not Be Used in Women Who May Become Pregnant,Investigators say clinicians should rethink their use of valproate in women in what some researchers are calling a practice-altering finding.
December 2008 ,Medscape Medical News,Elderly Often Use Prescription and Nonprescription Medications Together,A study of community-dwelling older adults showed that nearly 1 in 25 individuals were potentially at risk for a major drug-drug interaction.
December 2008 ,Heartwire from Medscape,FDA and Diabetes Drugs,The recommendation that diabetes drugs must show cardiovascular safety is included in a new guidance document issued this week by the agency and emerges after concerns have been raised about drugs in this field. More than 100 letters have been sent to drug companies informing them of the new recommendations.
December 2008 ,Medscape Medical News,FDA Requires Warnings About Suicidality Risk With Antiepileptic Drugs,The US Food and Drug Administration will require the manufacturers of antiepileptic drugs to add a warning to their labeling that use of the drugs increases risk for suicidal thoughts and behaviors.
December 2008 ,Medscape Medical News,New Case of PML with Natalizumab Monotherapy,"Biogen Idec and Elan reported to the SEC that another case of PML has been seen with natalizumab therapy in a patient with MS. The case was found through surveillance, the companies note, and the patient is stable."
December 2008 ,Medscape Medical News,Adverse Event Reporting Systems May Need Improvement,A national survey evaluated the present status of US hospital-based adverse event reporting systems and suggested needed improvements in reporting processes.
December 2008 ,Medscape Medical News,Oral Sodium Phosphate Products Linked to Acute Phosphate Nephropathy,The use of oral sodium phosphate products has been tied to acute phosphate nephropathy.
December 2008 ,WebMD Health News,FDA Panel Urges Restrictions on 2 Asthma Drugs,Experts urged the FDA to communicate to doctors that Serevent and Foradil inhalers should not be used alone.
December 2008 ,WebMD Health News,FDA Panel Asks: Are Asthma Drugs Safe?,"Serevent, Symbicort, and Foradil are the focus of a triple FDA panel meeting investigating their safety."
December 2008 ,Medscape Medical News,Panel Disputes FDA Finding on Antiepileptics and Risk for Suicide,"The methodology of meta-analysis is flawed, a panel says, and the decision will have unfortunate consequences for patients and the future of AED clinical trials."
December 2008 ,Heartwire from Medscape,CDC Provides Details on Heparin Investigation,"A new paper tells the story of how the CDC, after identifying oversulfated chondroitin as the plausible culprit contaminant, linked products containing the contaminant to the clinical symptoms of patients treated across 21 facilities in 13 states."
November 2008 ,Medscape Medical News,More Research Urgently Needed on Off-Label Use of 14 Drugs,A quantitative analysis identified particular concerns regarding safety of off-label use of antipsychotic and antidepressant drugs.
November 2008 ,Medscape Medical News,FDA Investigates Genetic Link to Phenytoin Skin Reactions,Clinicians should avoid the antiepileptic drugs phenytoin and fosphenytoin as alternatives to carbamazepine therapy in patients positive for the HLA-B*1502 allele.
November 2008 ,Heartwire from Medscape,"Higher Mortality, CHF With Rosiglitazone","A retrospective analysis of Medicare beneficiaries found all-cause mortality to be increased by 15% in patients taking rosiglitazone, while congestive heart failure hospitalizations were 13% higher. Stroke and MI, however, were no different between the treatment groups."
February 2009 ,Medscape Medical News,Boxed Warning Added to Metoclopramide-Containing Drugs,The FDA says that a boxed warning about the risk for tardive dyskinesia during long-term or high-dose use must be added to the drug labels of metoclopramide-containing drugs.
February 2009 ,Medscape Medical News,More Caution Needed for Warfarin Use in Chronic Kidney Disease,A prospective study suggests that warfarin may need to be started at a lower dosage and monitored more closely in patients with moderate or severe chronic kidney disease vs the general population.
February 2009 ,Medscape Medical News,Antiepileptic Drug Linked to Metabolic Acidosis,"The FDA recommends that healthcare professionals measure serum bicarbonate before initiating therapy and during treatment with zonisamide (Zonegran), even when symptoms are absent."
February 2009 ,Medscape Medical News,Drug Linked to Deaths From Progressive Multifocal Leukoencephalopathy,"Three deaths from PML and a possible fourth case have been reported in patients taking the immunosuppressant drug efalizumab, according to the FDA."
February 2009 ,Medscape Medical News,Certain Skin-Related Adverse Drug Events May Have Genetic Basis,"In the first initial data released by the Food and Drug Administration in conjunction with the International Serious Adverse Events Consortium, the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, are described. The data are expected to help better predict an individual's risk of developing these reactions."
February 2009 ,Medscape Medical News,Long-Term Use of Popular Inhalers May Increase Risk for Pneumonia in COPD,Inhaled corticosteroid use for at least 24 weeks in patients with chronic obstructive pulmonary disease was associated with a significantly increased risk for serious pneumonia but not for death.
February 2009 ,Medscape Medical News,"FDA Safety Changes: Promethazine and Codeine Oral Solution, Ranexa, Ethyol","The FDA has approved revisions to the safety labeling for promethazine HCl and codeine phosphate oral solution, ranolazine extended-release tablets, and amifostine injection."
February 2009 ,Medscape Medical News,"FDA Safety Changes: Selzentry, Triglide, Neulasta","The FDA has approved revisions to the safety labeling for maraviroc tablets, fenofibrate tablets, and pegfilgrastim."
February 2009 ,Medscape Medical News,FDA Continues to Investigate Bleeding Risk for Xigris,"The Food and Drug Administration announced today that is continuing to evaluate the incidence of serious bleeding events and death in patients who receive drotrecogin alfa activated, a recombinant human activated protein C indicated for the treatment of severe sepsis."
January 2009 ,Heartwire from Medscape,Clopidogrel and PPIs,"The findings support suspicions that the drug combination diminishes the beneficial effect of the antiplatelet therapy and increases the risk of future events, say researchers."
January 2009 ,Heartwire from Medscape,Generics Manufacturer Suspends More Than 100 Products,"A unit of KV Pharmaceutical has stopped manufacturing and selling more than 100 products, including antianginal nitrates and calcium-channel blockers."
January 2009 ,Medscape Medical News,FDA Safety Changes: Cordarone and Exjade,The FDA has approved revisions to the safety labeling for amiodarone HCl tablets and deferasirox tablets for oral suspension.
January 2009 ,Medscape Medical News,Loop Diuretic Use Linked to Higher Fracture Risk in Postmenopausal Women,"After adjustment for confounding variables, a study shows no significant association between ever-use of loop diuretics and changes in bone mineral density, falls, and fractures."
January 2009 ,Heartwire from Medscape,COGENT 1 Scrapped; Sponsor Bankrupt,The trial was testing a single-pill combination of clopidogrel and omeprazole to reduce the incidence of GI side effects.
January 2009 ,Medscape Medical News,"FDA Safety Changes: Prevacid NapraPAC 500, Prezista, Arixtra","The FDA has approved revisions to the safety labeling for lansoprazole delayed-release capsules and naproxen tablet kit, darunavir tablets, and fondaparinux sodium injection."
January 2009 ,Medscape Medical News,FDA Safety Changes: Atrovent and Atripla,The FDA has approved revisions to the safety labeling for ipratropium Br nasal spray (Atrovent) and for efavirenz/emtricitabine/tenofovir disoproxil fumarate tablets (Atripla).
January 2009 ,Medscape Medical News,Tainted Weight Loss Drugs,"The expanded list ups the number of contaminated products from 28 to 69. Many of these ""natural"" or ""herbal"" products contained sibutramine, phenolphthalein, and even rimonabant."
January 2009 ,Heartwire from Medscape,WSJ on Rosiglitazone,A report by the Wall Street Journal reveals that GlaxoSmithKline had similar concerns about rosiglitazone as the researchers who first raised alarms about the diabetes drug.
January 2009 ,Heartwire from Medscape,FDA Pilot Program,"The FDA is to launch a pilot program to help promote the safety of drugs and active pharmaceutical ingredients produced outside the US, with around 100 voluntary applicants to be selected for participation."
January 2009 ,Heartwire from Medscape,Sidney Wolfe Joins FDA Safety Committee: WSJ,"Dr Sidney Wolfe was appointed to the FDA Safety and Risk Managemnet Committee in August 2008, according to the WSJ."
April 2009 ,Medscape Medical News,Online System May Help Identify Patterns of Adverse Surgical Events,"A study suggests that a user-friendly, Web-based system to track morbidity, mortality, and near-misses should be used by surgery departments to identify quality improvement opportunities."
April 2009 ,Medscape Medical News,Zoledronic Acid Infusion Effective for Bone Loss Linked With Glucocorticoid Use,"In a randomized trial, a single 5-mg intravenous infusion of zoledronic acid was more acceptable to patients vs 5 mg of oral risedronate daily to prevent and treat glucocorticoid-related bone loss."
April 2009 ,Medscape Medical News,Tadalafil or Sildenafil Not Linked to Visual Effects With 6 Months of Daily Use,"In a randomized trial of medications for erectile dysfunction, no abnormalities in electroretinography or visual function and no treatment-related findings suggestive of drug toxicity were observed."
April 2009 ,Medscape Medical News,"FDA Safety Changes: Toprol XL, Revlimid, Fludara","The FDA has approved safety labeling revisions for metoprolol succinate extended-release tablets (Toprol-XL), lenalidomide (Revlimid), and fludarabine phosphate intravenous infusion (Fludara)."
April 2009 ,Medscape Medical News,Combined Oral Contraceptive Use Linked to Risk for Systemic Lupus Erythematosus,"Ceftriaxone can now be administered concomitantly with calcium-containing products in patients older than 28 days, updating a previous recommendation contraindicating this combination in all age groups."
April 2009 ,Medscape Medical News,Ceftriaxone Can Be Administered With Calcium-Containing Products in Certain Patients,The new labeling changes for lopinavir/ritonavir include warnings and precautions regarding QT/QTC interval and PR interval prolongation.
April 2009 ,Medscape Medical News,FDA Issues Safety Labeling Changes for Kaletra ,"FDA Safety Changes: Luvox/Luvox CR, Altace, Capozide, Monopril/Monopril HCT, Furadantin"
April 2009 ,Medscape Medical News,"FDA Safety Changes: Luvox/Luvox CR, Altace, Capozide, Monopril/Monopril HCT, Furadantin","The agency said that saxagliptin does not pose a cardiovascular risk to diabetes patients, effectively recommending the drug for approval, while liraglutide was turned away by the advisory panel because of an increased risk of cancer observed in animal studies. "
April 2009 ,Heartwire from Medscape,"Saxagliptin Gets Favorable FDA Panel Review, While Liragutide Not Recommended for Approval","The FDA has approved revisions to the safety labeling for bosentan tablets, esomeprazole injection, esomeprazole magnesium delayed-release capsules and oral suspension, and tigecycline injection."
April 2009 ,Medscape Medical News,"FDA Safety Changes: Tracleer, Nexium, Nexium IV, Tygacil ","Over a four-year period, the rates of cancer-associated adverse events and the proportion of all reported adverse events related to cancer were less than event rates observed with other potent cholesterol-lowering medications."
March 2009 ,Heartwire from Medscape,FDA Postmarketing Surveillance Data Show No Cancer Risk With Ezetimibe,"The FDA has approved revisions to the safety labeling for various selective serotonin and serotonin-norepinephrine reuptake inhibitors; multiple electrolytes injection, type 1; and telbivudine."
March 2009 ,Medscape Medical News,"FDA Safety Changes: Antidepressants, Plasma-Lyte 148, Tyzeka","Watson Pharmaceuticals has recalled one lot of propafenone HCl 250 mg packed in 100-count bottles it said was shipped to customers between October 15, 2008 and November 26, 2008."
March 2009 ,Heartwire from Medscape,Watson Pharma Recalls One Lot of Propafenone 225 mg,Insulin pens and cartridges should not be used in multiple patients because of the risk for transmission of blood-borne pathogens.
March 2009 ,Medscape Medical News,"FDA Warns Against Sharing Single-Use Insulin Pens, Cartridges","The FDA has approved revisions to the safety labeling for hydrocodone bitartrate and homatropine methylbromide, benazepril, benazepril plus hydrochlorothiazide, and cefdinir."
March 2009 ,Medscape Medical News,"FDA Safety Changes: Hycodan, Lotensin, Lotensin HCT, Omnicef","The FDA has approved revisions to the safety labeling for celecoxib capsules (Celebrex), indinavir sulfate tablets (Crixivan), and isoniazid plus pyrazinamide and rifampin tablets (Rifater)."
March 2009 ,Medscape Medical News,"FDA Safety Changes: Celebrex, Crixivan, Rifater","The FDA has approved revisions to the safety labeling for anastrozole tablets (Arimidex), carvedilol tablets and extended-release tablets (Coreg, Coreg CR), and alglucosidase alfa injection (Myozyme)."
March 2009 ,Medscape Medical News,"FDA Safety Changes: Arimidex, Coreg/Coreg CR, Myozyme",A study shows that antibiotic use in the first year of life is linked to a small risk for the development of asthma and that the risk increases with the number of courses of antibiotics prescribed.
March 2009 ,Medscape Medical News,Antibiotic Use in First Year of Life Linked to Risk of Developing Asthma,Certain transdermal patches containing even small traces of aluminum or other metals in the adhesive backing can cause skin burns if worn during magnetic resonance imaging.
March 2009 ,Medscape Medical News,"Medicated Patch Can Cause Burns During MRI, FDA Warns","The FDA has approved revisions to the safety labeling for ipratropium bromide and albuterol sulfate inhalation aerosol, quinine sulfate capsules, and sacrosidase oral solution."
June 2009 ,Medscape Medical News,FDA Safety Changes: Exjade and Extraneal,The FDA has approved safety labeling revisions for deferasirox tablets for oral suspension (Exjade) and icodextrin peritoneal dialysis solution (Extraneal).
June 2009 ,Medscape Medical News,"Propylthiouracil Linked With Risk for Serious Liver Damage, Death","The FDA has issued a safety alert about the risk for serious liver damage, including liver failure, or death with propylthiouracil compared with methimazole."
June 2009 ,Medscape Medical News,Proton-Pump Inhibitors Increase Risk for Hospital-Acquired Pneumonia,"In a large, prospective, hospital-based pharmacoepidemiologic cohort, acid suppressive medication use was associated with 30% increased odds of hospital-acquired pneumonia."
June 2009 ,Medscape Medical News,FDA Safety Changes: Remicade and Doribax,The FDA has approved safety labeling revisions for infliximab intravenous infusion (Remicade) and doripenem intravenous infusion (Doribax).
May 2009 ,Medscape Medical News,"FDA Safety Changes: Advair Diskus, Orap, Rocephin","The FDA has approved safety labeling revisions for fluticasone propionate and salmeterol xinafoate inhalation powder, pimozide tablets, and ceftriaxone sodium injection."
May 2009 ,WebMD Health News,Cancer Drug Erases Man's Fingerprints,A traveler was temporarily denied entry into the U.S. because of a side effect of Xeloda.
May 2009 ,Medscape Medical News,Postdischarge Adverse Events Are Common,"The timing and type of follow-up of older discharged patients might need to change, according to a new study."
May 2009 ,Medscape Medical News,Cholinesterase Inhibitors Linked to Serious Adverse Events in Older Adults With Dementia,"A population-based cohort study suggests that the risks for syncope, bradycardia, pacemaker insertion, and hip fracture must be weighed carefully against the generally modest benefits of cholinesterase inhibitors."
May 2009 ,Medscape Medical News,Tamsulosin Use Linked to Serious Ophthalmic Adverse Events After Cataract Surgery,"Use of tamsulosin within 14 days of cataract surgery, but not of other alpha-blocker medications used to treat benign prostatic hyperplasia, was significantly associated with serious postoperative ophthalmic adverse events."
May 2009 ,Medscape Medical News,"FDA Safety Changes: Zithromax, Frova, Lexiscan","The FDA has approved safety labeling revisions for azithromycin tablets and oral suspension (Zithromax), frovatriptan succinate tablets (Frova), and regadenoson injection (Lexiscan)."
May 2009 ,Heartwire from Medscape,Merck Defense Begins in Oz,Lawyers for Merck began their defense this week in the rofecoxib class-action lawsuit that is ongoing in Australia. They will have to counter many astonishing allegations that have been made in court in Melbourne over the past few weeks.
May 2009 ,Medscape Medical News,"FDA Safety Changes: Visicol, OsmoPrep, DiaBeta, Raptiva","The FDA has approved safety labeling revisions for sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous tablets (Visicol and OsmoPrep), glyburide tablets (DiaBeta), and efalizumab subcutaneous injection (Raptiva)."
May 2009 ,Medscape Medical News,"FDA Safety Changes: Axert, Tarka, Macrobid, Macrodantin","The FDA has approved safety labeling revisions for almotriptan malate tablets (Axert), verapamil HCl/trandolapril tablets (Tarka), and nitrofurantoin monohydrate/macrocrystals capsules (Macrobid and Macrodantin)."
May 2009 ,WebMD Health News,Hydroxycut Recall Due to Liver Injuries,FDA says people should stop using the diet products immediately.
May 2009 ,Reuters Health Information,Antibiotic Use in Childhood Not Linked to Type 1 Diabetes,"Contrary to what several other studies have shown, the results of a nationwide study of Danish children suggest that antibiotic use does not affect the development of type 1 diabetes."
April 2009 ,Medscape Medical News,FDA Safety Changes: Sporanox and Novothyrox,The FDA has approved safety labeling revisions for itraconazole (Sporanox) and levothyroxine sodium tablets (Novothyrox).
April 2009 ,Medscape Medical News,"FDA Safety Changes: Epzicom, Trizivir, Tracleer","The FDA has approved safety labeling revisions for abacavir sulfate and lamivudine tablets (Epzicom), abacavir plus lamivudine and zidovudine tablets (Trizivir), and bosentan tablets (Tracleer)."
April 2009 ,Medscape Medical News,New Electronic Medication Intervention Appears to Decrease Potential Adverse Drug Events,A computerized medication reconciliation tool and process redesign was associated with a decrease in unintentional medication discrepancies with potential for patient harm.
April 2009 ,Medscape Medical News,"FDA Safety Changes: Zantac, Zithromax, Noxafil"," The FDA has approved safety labeling revisions for ranitidine HCl, azithromycin, and posaconazole."
April 2009 ,Medscape Medical News,"FDA Safety Changes: Comtan, Stalevo, Tasmar, Symmetrel, Xenical, Casodex","The FDA has approved safety labeling revisions for entacapone tablets, levodopa/carbidopa/entacapone tablets, tolcapone tablets, amantadine HCl syrup and tablets, orlistat, and bicalutamide."
August 2009 ,Medscape Medical News,"FDA Safety Changes: Chantix, DiaBeta, Aralen","The FDA has approved safety labeling revisions for varenicline tartrate tablets (Chantix), glyburide tablets (DiaBeta), and chloroquine phosphate tablets (Aralen)."
August 2009 ,Medscape Medical News,"FDA Safety Changes: Strattera, Aptivus, CellCept","The FDA has approved safety labeling revisions for atomoxetine HCl capsules; tipranavir capsules and oral solution; and mycophenolate mofetil capsules, tablets, injection, and oral suspension."
August 2009 ,Medscape Medical News,FDA Updates Warnings for TNF Blockers and Cancer Risk,The FDA is requiring stronger warnings regarding the risk for cancer associated with tumor necrosis factor blockers.
July 2009 ,Medscape Medical News,"FDA Safety Changes: Rocephin, Amaryl, Prandin","The FDA has approved safety labeling revisions for ceftriaxone sodium injection (Rocephin), glimepiride tablets (Amaryl), and repaglinide tablets (Prandin)."
July 2009 ,Medscape Medical News,"FDA Safety Changes: Aristospan, Videx/Videx EC, Coreg/Coreg ER","The FDA has approved safety labeling revisions for triamcinolone hexacetonide, didanosine oral solution and delayed-release capsules, carvedilol tablets, and carvedilol extended-release tablets."
July 2009 ,Medscape Medical News,Benefits of Intensive Methotrexate Treatment Outweigh Adverse Events in Early Rheumatoid Arthritis,A study of methotrexate in patients with rheumatoid arthritis shows a higher occurrence of adverse events but better clinical efficacy with intensive treatment vs conventional treatment with the drug.
July 2009 ,Medscape Medical News,"Methylphenidate, Amphetamines Show Cardiac Risks in Children With ADHD","In a retrospective study, use of methylphenidate and amphetamines shows a similar risk for cardiac emergency department visits in children and adolescents with attention-deficit/hyperactivity disorder."
July 2009 ,Medscape Medical News,Omalizumab May Be Linked to Cardiovascular Adverse Events,Results of an interim analysis suggest that omalizumab (Xolair) may be associated with a disproportionate increase in the incidence of certain cardiovascular adverse events.
July 2009 ,Medscape Medical News,FDA Safety Changes: Reglan and Prometrium,"The FDA has approved safety labeling revisions for metoclopramide tablets, orally disintegrating tablets, and injection (Reglan); and progesterone capsules (Prometrium)."
July 2009 ,Medscape Medical News,"Drug-Induced Acute Liver Failure Very Rare, but Can Be Fatal","A study shows that acetaminophen is the most common cause of drug-induced acute liver failure, accounting for nearly half of cases in adults, but other drugs can also be responsible."
July 2009 ,Medscape Medical News,Methylphenidate Well Tolerated by Childhood Cancer Survivors,"In childhood cancer survivors, overall tolerability of methylphenidate was good, but a subgroup was at increased risk for adverse effects that may need close monitoring or prescription of a lower dose."
July 2009 ,Medscape Medical News,"Famotidine Prevents Peptic Ulcers, Esophagitis in Patients Taking Aspirin","Famotidine is effective in preventing gastric and duodenal ulcers, and erosive esophagitis in patients taking low-dose aspirin for vascular protection, a phase 3 study reveals."
July 2009 ,Medscape Medical News,Ketamine May Be Useful for Intubation in Critically Ill Patients,"A randomized controlled, single-blind trial shows that ketamine is a safe, valuable alternative to conventional etomidate to use as a sedative during intubation in critically ill patients."
July 2009 ,Medscape Medical News,Insulin Glargine Potentially Associated With Increased Cancer Risk ,"The increased risk has been seen in 3 of 4 observational studies, but these findings warrant further follow-up studies to confirm an association, according to the FDA."
July 2009 ,Medscape Medical News,Chantix and Zyban to Receive Boxed Warnings for Serious Neuropsychiatric Symptoms,"Varenicline and bupropion are receiving boxed warnings regarding the risks for changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide."
July 2009 ,Medscape Medical News,"FDA Safety Changes: Prevpac, Arava, Treanda","The FDA has approved safety labeling revisions for a prepackaged regimen of lansoprazole, amoxicillin, and clarithromycin tablets; leflunomide tablets; and bendamustine HCl intravenous infusion."
June 2009 ,Medscape Medical News,Contrast-Induced Nephropathy May Be Linked to Long-Term Adverse Events,"After adjustment for baseline comorbidities and risk factors, the incidence rate ratio for adverse events was twice as high in those with CIN defined stringently."
June 2009 ,Medscape Medical News,"FDA Safety Changes: Kerlone, Meridia, Stromectol","The FDA has approved safety labeling revisions for betaxolol HCl tablets (Kerlone), sibutramine HCl monohydrate capsules (Meridia), and ivermectin tablets (Stromectol)."
June 2009 ,Medscape Medical News,"FDA Safety Changes: Minipress, Letairis, Coly-Mycin M Parenteral","The FDA has approved safety labeling revisions for prazosin HCl capsules (Minipress), ambrisentan tablets (Letairis), and colistimethate injection (Coly-Mycin M Parenteral)."
June 2009 ,Medscape Medical News,"FDA Safety Changes: Sarafem, Mavik, Cordarone","The FDA has approved safety labeling revisions for deferasirox tablets for fluoxetine HCl (Sarafem tablets), trandolapril (Mavik tablets), and amiodarone HCl (Cordarone tablets)."
October 2009 ,Medscape Medical News,Neuron 070 Delivery Catheters Recalled Due to Kinking,Delivery catheters are being voluntarily recalled by their manufacturer because of kinking and/or ovalization of the catheter lumen; 4 injuries possibly associated with this defect have been reported.
September 2009 ,Medscape Medical News,FDA Issues Risk Communication Plan for Providing Public Health Information ,A new FDA plan issued today outlines how information on FDA-regulated products will be disseminated to the public.
September 2009 ,Medscape Medical News,"FDA Safety Changes: Zyprexa, Geodon, Lariam, Merrem IV, Primaxin","The FDA has approved safety labeling revisions for olanzapine, ziprasidone, mefloquine HCl tablets, meropenem, and imipenem/cilastatin."
September 2009 ,Heartwire from Medscape,New Study Helps to Characterize Heparin-Induced Skin Lesions,"A new prospective study has found the incidence of heparin-induced skin lesions to be around 7.5%. Women, the obese, and those on heparin therapy for longest are most at risk."
September 2009 ,Medscape Medical News,Hormone Replacement Therapy Linked to Risk for Death From Lung Cancer,"In an analysis of data from the Women's Health Initiative, hormone replacement therapy with use of estrogen and progestin was associated with increased risk for death from lung cancer."
September 2009 ,Medscape Medical News,Septic Shock from Surgical Mesh for Pelvic Organ Prolapse ,The case of a 61-year old woman presenting with septic shock 6 weeks after transvaginal placement of polypropylene mesh for pelvic organ prolapse highlights problems with FDA notification.
September 2009 ,Medscape Medical News,FDA Issues Early Communication Regarding Deferasirox Safety in MDS,"Patients receiving deferasirox who have myelodysplastic syndrome may be at greater risk for adverse events such as kidney failure, gastrointestinal hemorrhage, and fatalities."
September 2009 ,Medscape Medical News,"Sitagliptin Linked to Acute Pancreatitis, FDA Warns","The FDA is revising prescribing information for sitagliptin (Januvia) and sitagliptin/metformin (Janumet) after cases of acute pancreatitis, some severe, surfaced in postmarketing reports."
September 2009 ,Medscape Medical News,Potential Dosing Errors With Oseltamivir in Children,"US clinicians usually prescribe liquid medicines in milliliters (mL) or teaspoons, but Tamiflu is dosed in milligrams (mg), and the dispenser is marked only in 30, 45, and 60 mg."
September 2009 ,Medscape Medical News,Natalizumab Associated With Ongoing Cases of PML,"Rare but ongoing cases of PML continue to be associated with the use of natalizumab, according to the FDA."
September 2009 ,Medscape Medical News,"FDA Safety Changes: Metronidazole Injection, DexFerrum, INFeD, Tasigna","The FDA has approved safety labeling revisions for metronidazole injection, iron dextran injection (DexFerrum and INFeD), and nilotinib HCl monohydrate capsules (Tasigna)."
September 2009 ,Medscape Medical News,FDA Adds Boxed Warning to Injectable Promethazine,"Intravenous administration of promethazine can cause severe tissue injury, including gangrene, requiring fasciotomy, skin graft, and/or amputation, according to the FDA."
September 2009 ,Medscape Medical News,Depot Medroxyprogesterone Acetate and Fracture Risk in Young Women,"Prolonged depot medroxyprogesterone acetate contraceptive use is associated with an increased risk for fractures in women, but socioeconomic confounders might be clouding the findings."
September 2009 ,Medscape Medical News,Budesonide for 12 Months Not Linked to Pneumonia Risk in COPD Patients,Budesonide treatment for 12 months did not increase the risk for pneumonia in patients with chronic obstructive pulmonary disease during that time and was safe for clinical use in such patients.
September 2009 ,Medscape Medical News,"FDA Safety Changes: Actonel, Gardasil, Myfortic","The FDA has approved safety labeling revisions for risedronate sodium tablets, human papillomavirus quadrivalent [recombinant] vaccine, and mycophenolic acid delayed-release tablets."
September 2009 ,Medscape Medical News,Hormonal Therapy for Breast Cancer May Affect Contralateral Cancer Risk,Long-term tamoxifen use was linked to a lower risk for contralateral estrogen receptor–positive breast cancer but a 4.4-fold increased risk for contralateral estrogen receptor–negative breast cancer.
September 2009 ,Medscape Medical News,Q&As on Cancer Risk With TNF Blockers in Children,"The FDA announced yesterday it has posted supplemental Q&As on the increased risk for lymphoma and other cancers in children and adolescents receiving the tumor necrosis factor (TNF) blockers infliximab (Remicade), adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), and golimumab (Simponi)."
August 2009 ,Medscape Medical News,FDA Revises Warning for Etravirine,The FDA has issued an alert to warn of severe skin reactions and possible life-threatening adverse events in patients who use etravirine.
August 2009 ,Medscape Medical News,FDA to Investigate Liver-Related Adverse Events Seen With Orlistat,The FDA has warned healthcare professionals about the potential for liver-related adverse events with the weight-loss drug orlistat.
August 2009 ,Medscape Medical News,Accusure Insulin Syringes Voluntarily Recalled,Accusure insulin syringes distributed nationwide from January 2007 through June 2008 are undergoing voluntary recall because of the detachment of needles from the syringes.
December 2009 ,Medscape Medical News,Medroxyprogesterone Helpful for Hot Flushes in Men Receiving Hormone Therapy,"In a randomized trial, medroxyprogesterone was the best treatment of hot flushes in men undergoing hormone therapy for prostate cancer."
December 2009 ,Medscape Medical News,Potential Benefits of Shock Wave Lithotripsy May Outweigh Risks,A white paper from the American Urological Association states that the potential benefits of shock wave lithotripsy outweigh the foreseeable risks.
November 2009 ,Medscape Medical News,Acetaminophen Use During Pregnancy May Not Increase Asthma Risk in Offspring,"In a prospective study, acetaminophen use during pregnancy was not associated with an increased risk for asthma in the children."
November 2009 ,Medscape Medical News,Patients and Doctors Differ When Reporting Adverse Events,"Although clinician and patient reporting of treatment-related adverse effects differ from each another, together they are complementary and provide a more complete picture."
November 2009 ,Medscape Medical News,Certain Genzyme Products for Rare Disorders Potentially Contaminated,"Certain Genzyme products may be contaminated with stainless steel particles and other foreign matter, and the FDA recommends careful visual inspection of the products before use."
November 2009 ,Medscape Medical News,Infusion of Local Anesthetic Linked to Postsurgical Chondrolysis,Chondrolysis has been reported in patients receiving continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control postsurgical pain.
November 2009 ,Medscape Medical News,"FDA Safety Changes: DepoDur, Neoral, Lexiva","The FDA has approved safety labeling revisions for morphine sulfate extended-release liposome injection, cyclosporine capsules and oral solution, and fosamprenavir calcium tablets and oral suspension."
October 2009 ,Medscape Medical News,"More Suicidal Ideation With Nortriptyline vs Escitalopram Among Men, but Both Drugs Decrease Adverse Effects","Men treated for depression with nortriptyline had almost a 10-fold increase in suicidal thoughts at 5 weeks vs men treated with escitalopram, but both drugs effectively reduced suicidal ideation."
October 2009 ,Medscape Medical News,"FDA Safety Changes: Ultram, Ultracet, Sustiva, Kayexalate","The FDA has approved safety labeling revisions for tramadol HCl tablets, tramadol plus acetaminophen tablets, efavirenz capsules and tablets, and sodium polystyrene sulfonate powder."
October 2009 ,Medscape Medical News,Thiopurine for IBD Linked to Risk for Lymphoproliferative Disorders,"In a prospective observational cohort study, patients receiving thiopurines for inflammatory bowel disease had an increased risk for the development of lymphoproliferative disorders."
October 2009 ,Heartwire from Medscape,Event Rates and Trial Results,The low event rate in the RECORD trial of rosiglitazone has led some to question the validity of the results.
October 2009 ,Medscape Medical News,Nontramadol Opioids Should Not Be Routinely Used for Osteoarthritis,": In a review, small to moderate benefits of nontramadol opioids were outweighed by large increases in risk for adverse events; these should not be used routinely even if osteoarthritic pain is severe."
October 2009 ,Medscape Medical News,"FDA Safety Changes: Symbyax, Zoladex, INOmax","The FDA has approved safety labeling revisions for olanzapine/fluoxetine HCl capsules (Symbyax), goserelin acetate implants (Zoladex), and nitric oxide for inhalation (INOmax)."
October 2009 ,Heartwire from Medscape,SLCO1B1 Gene,"Carriers of the SLCO1B1*5 allele are at a twofold increased risk of mild statin-induced side effects, and the majority of these individuals had normal creatine-kinase levels."
October 2009 ,Medscape Medical News,Certain Prophylactic Medications Reduce Risk for Breast Cancer but May Increase Other Risks,"A systematic review shows a reduced risk for primary breast cancer but an increased risk for thromboembolic events (tamoxifen, raloxifene), endometrial cancer (tamoxifen), or stroke (tibolone)."
October 2009 ,Medscape Medical News,New-Onset Breast Tenderness During Hormone Therapy Linked to Breast Cancer Risk,"In a randomized controlled trial, new-onset breast tenderness during conjugated equine estrogens plus medroxyprogesterone therapy was associated with increased breast cancer risk."
October 2009 ,Medscape Medical News,FDA Warns Against Use of Zanamivir With Nebulizer,The FDA and GlaxoSmithKline are reporting the death of a person with influenza after receiving zanamivir inhalation powder (Relenza) that had been dissolved and administered with a nebulizer.
October 2009 ,Medscape Medical News,ACEIs More Likely Than Other Antihypertensive Drugs to Cause Hyperkalemia,"However, in nondiabetic patients with hypertensive chronic kidney disease treated with angiotensin-converting enzyme inhibitors, the risk for hyperkalemia is small."
October 2009 ,Medscape Medical News,"FDA Safety Changes: Arixtra, Sulfonylureas, Tobramycin","The FDA has approved safety labeling revisions for fondaparinux sodium, glipizide and glipizide extended-release tablets, micronized glyburide, glipizide/metformin, glyburide, and tobramycin."
October 2009 ,Medscape Medical News,Thiazolidinediones Linked to Bone Fracture Risk,"In a UK database study, nearly one and half times as many fractures occurred when people were taking thiazolidinediones than when they were not taking these drugs, after adjustment for age."
March 2010 ,Medscape Medical News,Antidepressants May Permanently or Reversibly Affect Fetal Brain Development,The timing of antidepressant exposure during pregnancy may determine whether the effects on fetal brain development are permanent or reversible.
March 2010 ,Heartwire from Medscape,"Statin ""Preconditioning"" Effect Blunted by COX-2 Inhibitor in Volunteers",The COX-2 inhibitor celecoxib completely abolished the beneficial preconditioning effect of rosuvastatin in a small mechanistic study in human volunteers.
February 2010 ,Heartwire from Medscape,GlaxoSmithKline Fires Back,"In its response, the company states it has been ""proactive in investigating the safety data"" of rosiglitazone and is critical of the Senate report that ignores other data, including DREAM, ADOPT, and RECORD."
February 2010 ,Medscape Medical News,Thiazolidinedione Use Linked to Increased Fracture Risk in Women,"A study shows that thiazolidinedione use is associated with an increased risk for fractures in women, particularly in those older than 65 years."
February 2010 ,Heartwire from Medscape,Saquinavir and Ritonavir: Arrhythmia Risks ,"Preliminary data suggest that the combination of saquinavir and ritonavir may cause prolongation of the QT and PR intervals, leading to an increased risk of torsades de pointes and heart block, respectively."
February 2010 ,Medscape Medical News,"FDA Studying 27 Drugs, Drug Classes for Potential Safety Issues",A medication's appearance on the list does not mean physicians should stop prescribing it.
February 2010 ,Medscape Medical News,FDA Mandates New Safety Controls for Long-Acting Beta Agonists,"Once asthma control is achieved, patients should be switched from combination corticosteroid-LABA therapy to a corticosteroid or another long-term asthma controller medication without a LABA."
February 2010 ,Medscape Medical News,New Boxed Warning for Deferasirox,The prescribing information for deferasirox has been updated to describe risks for kidney and liver failure and gastrointestinal hemorrhage and includes a new black box warning.
February 2010 ,WebMD Health News,FDA Warns of Maalox Mix-up Danger,The agency says some consumers are confusing Maalox antacids with a product called 'Maalox Total Relief.''
February 2010 ,Medscape Medical News,HRT With Estrogen Alone Increases Risk for Asthma Onset After Menopause,"Estrogen-only hormone replacement therapy has been found to be linked to an increased risk for the development of asthma after menopause, according to a large cohort study of postmenopausal women."
February 2010 ,Heartwire from Medscape,Avandia Raises Heart-Failure Risk in RECORD Randomized Trial,The secondary finding from the controversial trial is consistent with an interim analysis conducted several years ago.
February 2010 ,Medscape Medical News,Deaths From Methadone Overdose Disproportionate to Number of Prescriptions,A national review of opioid-related deaths finds that methadone plays a larger role than other drugs.
February 2010 ,Medscape Medical News,PML Risk Increases With Repeated Natalizumab Infusions: FDA,"The Food and Drug Administration released new safety information gleaned from the 31 cases of PML to date, but still conclude the clinical benefit for patients outweighs the risks. "
January 2010 ,Medscape Medical News,Didanosine Associated With Noncirrhotic Portal Hypertension,"Postmarketing reports of noncirrhotic portal hypertension, including 4 deaths, have resulted in an update of the didanosine label."
December 2009 ,Medscape Medical News,"Quitting Smoking, Increased Calcium May Lower BMD Loss Linked to DMPA Use",Quitting smoking and increasing calcium intake may reduce the risk for higher bone mineral density loss associated with use of depot medroxyprogesterone acetate.
December 2009 ,Medscape Medical News,Recommendations for Prescribing NSAIDs in the Primary Care Setting,A review article provides recommendations for prescribing nonsteroidal anti-inflammatory drugs in the primary care setting.
December 2009 ,Medscape Medical News,Intravitreal Triamcinolone May Slow Diabetic Retinopathy Progression,"Because adverse effects include cataract formation and glaucoma, the investigators did not recommend this treatment merely to reduce progression of proliferative diabetic retinopathy."
December 2009 ,Medscape Medical News,Low-Dose Aspirin During Pregnancy Has No Adverse Impact on Preterm Infants,"Aspirin may actually reduce neurobehavioral issues, according to a recent study."
December 2009 ,Reuters Health Information,High-Dose Inhaled Steroids for Asthma May Increase Risk of Fetal Malformations,The congenital malformation rate for pregnant women who used more than 1000 micrograms per day was much higher than that seen in nonusers and in users of no more than 1000 micrograms per day.
December 2009 ,Medscape Medical News,Suicide Warning on Epilepsy Drugs Intensifies Clinical Responsibility,New warnings on antiepileptic drugs unambiguously state the need to screen for psychiatric disorders and will have medical-legal implications for clinicians.
April 2010 ,Medscape Medical News,FDA Safety Changes: Lotrel,The FDA has approved revisions to the safety labeling for amlodipine besylate plus benazepril HCl capsules.
April 2010 ,Medscape Medical News,Medication Side Effects in Depressed Outpatients Often Go Undetected ,"New research shows clinicians only pick up a fraction of the side effects related to antidepressant medications, a finding that highlights the need for better monitoring experts say. "
April 2010 ,Medscape Medical News,FDA Safety Changes: Caduet,The FDA has approved revisions to the safety labeling for amlodipine besylate plus atorvastatin calcium tablets.
April 2010 ,Heartwire from Medscape,Discharge Clopidogrel Delay ups Events,"One in six patients do not immediately fill their initial prescription for clopidogrel after hospital discharge, and such a delay is associated with an increased risk of adverse outcomes, a new study shows. "
April 2010 ,Medscape Medical News,Similar Adverse Effects for Epilepsy Patients on Monotherapy or Polytherapy ,A new study suggests fear of increased toxicity with multiple drugs may not be warranted.
April 2010 ,Medscape Medical News,FDA Adds Boxed Warning to Propylthiouracil,"The new warning includes a postmarketing data review of cases of severe liver injury and acute liver failure, some fatal, as well as information on whether to use the drug in pregnancy."
April 2010 ,Heartwire from Medscape,Common UTI Antibiotic Risky in Warfarin Setting ,Urinary-tract infections are one of the most common infections in older patients taking warfarin; now new research shows that the most commonly used antibiotic may quadruple the risk of upper-GI bleeding.
April 2010 ,Medscape Medical News,FDA Tightens Approval Process for Radiotherapy Devices,The agency continues its war against equipment problems and operator errors that result in radiation overdoses.
April 2010 ,Medscape Medical News,Flu Shot Without Skin Testing May Be Safe for Egg-Allergic Patients,"A study suggests that patients without anaphylaxis to egg may safely receive the influenza vaccine in a 2-dose, graded fashion without a vaccine skin test."
April 2010 ,Medscape Medical News,Hormone Therapy for Menopause Reviewed,A review states that women must be informed of benefits and risks of all treatment options and should receive individualized care for menopausal symptoms.
April 2010 ,Medscape Medical News,Antepartum Antiviral Treatment of H1N1 Influenza Not Linked to Adverse Outcomes,"In a retrospective cohort study, there was no evidence of an association between antepartum antiviral exposure and adverse maternal or neonatal outcomes."
April 2010 ,Medscape Medical News,Antipsychotic Drugs May Boost Pneumonia Risk in Elderly Outpatients,"A case-control study finds the association was dose dependent, occurred with both atypical and typical antipsychotics, and appeared to be most pronounced during the first week of treatment. "
April 2010 ,Medscape Medical News,FDA Reviewing Data on Possible Increased Prostate Cancer Risk With Stalevo in PD ,The agency stresses their review is ongoing and no new conclusions or recommendations are being made at this time.
March 2010 ,Medscape Medical News,Overall Mortality in Type 2 Diabetes May Be Similar With Some Sulfonylureas,"Risk for overall mortality was similar in patients with type 2 diabetes receiving glipizide, glyburide, or glimepiride monotherapy, but glimepiride was preferred in those with coronary artery disease."
March 2010 ,Medscape Medical News,Femur Fractures Rare With Bisphosphonate Use," In an analysis of 3 trials, fractures of the subtrochanteric or diaphyseal femur were very rare, even in women treated with bisphosphonates for up to 10 years."
March 2010 ,Medscape Medical News,PPIs May Help Reduce Hospitalizations for Gastroduodenal Bleeding,Concurrent use of proton pump inhibitors in patients with serious coronary heart disease treated with clopidogrel was associated with fewer hospitalizations for gastroduodenal bleeding.
March 2010 ,Medscape Medical News,"High-Dose Simvastatin Associated With Increased Risk for Myopathy, FDA Warns","A simvastatin dose of 80 mg is associated with an increased risk for myopathy compared with lower doses and other statins, according to an FDA review of clinical trial and other data."
March 2010 ,Medscape Medical News,Oral Contraception May Not Increase Long-Term Mortality Rate,"In a large UK cohort, oral contraception was not associated with an increased long-term risk for death but was actually associated with a net benefit."
March 2010 ,Medscape Medical News,Norepinephrine and Dopamine in Treatment of Shock,"Although there was no significant difference in death rates between patients treated with dopamine and those treated with norepinephrine, dopamine was linked with twice as many adverse events."
March 2010 ,Medscape Medical News,Regular Analgesic Use May Increase Risk for Hearing Loss,"Regular use of aspirin, acetaminophen, and nonsteroidal anti-inflammatory drugs may increase the risk for hearing loss in men, particularly those younger than 60 years."
June 2010 ,Medscape Medical News,High-Dose B Vitamin Therapy May Not Be Helpful in Diabetic Nephropathy,"In a randomized trial in diabetic nephropathy, high doses of B vitamins vs placebo resulted in a greater decrease in glomerular filtration rate and an increase in vascular events."
June 2010 ,Medscape Medical News,FDA Warns Against Use of 3 Recalled IV Medications ,"The agency's announcement about the potential contamination risks for metronidazole, ciprofloxacin, and ondansetron follows a recall of metronidazole from Sagent Pharmaceuticals."
May 2010 ,Medscape Medical News,FDA Adds Risk for Severe Liver Injury to Orlistat Label,"The agency notes, however, that it has not yet established a cause-and-effect relationship between orlistat use and liver damage."
May 2010 ,Medscape Medical News,FDA Warns of Suicide Risk for Tramadol,The agency also is advising physicians that the opioid may be sought by patients with drug abuse and addiction problems or those with criminal diversion in mind.
May 2010 ,Medscape Medical News,"Proton Pump Inhibitors May Increase Fracture Risk, FDA Warns",Physicians should consider whether a lower dose or a shorter duration of PPI therapy would adequately treat gastroesophageal reflux disease and other indicated conditions.
May 2010 ,Medscape Medical News,FDA and NIH Launch Safety Reporting Web Site,"The new Safety Reporting Portal will deal with food safety, while MedWatch will remain focused on drugs and devices; the 2 Web sites will eventually merge. "
May 2010 ,Medscape Medical News,Long-Term Metformin Treatment Linked to Vitamin B12 Deficiency,"Long-term treatment with metformin increased the risk for vitamin B12 deficiency, which may be preventable, and increased homocysteine concentrations in patients with type 2 diabetes."
May 2010 ,Medscape Medical News,Dermatologic Use of Retinoid Drugs Not Linked to Increased Fracture Risk,"A case-control study shows that patients treated for acne, psoriasis, or another skin condition with vitamin A analogues are not at increased risk for fracture."
May 2010 ,Medscape Medical News,"Tapentadol Sometimes Better Tolerated, But Opioids Still First Line",A new post hoc analysis of 1-year safety data for tapentadol extended release in low back pain or osteoarthritis shows that the drug has a good safety profile.
May 2010 ,Medscape Medical News,Hyaluronidase Product Recalled Because of Contamination,A voluntary recall has been issued for all lots of Baxter's hyaluronidase human injection because of the presence of particulate matter.
May 2010 ,Medscape Medical News,Sagent Pharmaceuticals Recalls Metronidazole Injection,The voluntary nationwide recall of the antibiotic follows the discovery of 2 lots that were not sterile.
May 2010 ,Medscape Medical News,Promacta Study Halted Due to Increased Risk for Portal Venous Thrombosis in Liver Disease Patients,"In the ELEVATE study, 4% of patients receiving eltrombopag and 1% of those receiving placebo developed portal venous thrombosis."
May 2010 ,WebMD Health News,FDA: Don't Swallow Benadryl Gel,The agency warns of serious side effects in people who mistakenly swallow Benadryl Extra Strength Itch Stopping Gel.
May 2010 ,Medscape Medical News,High-Dose PPIs May Be No More Effective Than Lower Doses for Bleeding Peptic Ulcer,"Compared with non-high-dose proton pump inhibitors, high doses did not further reduce rates of rebleeding, surgical intervention, or mortality after endoscopic treatment of bleeding peptic ulcer."
May 2010 ,Medscape Medical News,"PPI Use Not Linked With Hip Fractures, but Modestly With Other Types of Fractures","In postmenopausal women, use of proton pump inhibitors was, however, modestly associated with clinical spine fractures, forearm or wrist fractures, and total fractures."
May 2010 ,Medscape Medical News,Proton Pump Inhibitor Use Linked to Clostridium Difficile Infection,A study shows a 74% increase in Clostridium difficile infection with daily use of proton pump inhibitors; a second study shows a 42% increased risk for recurrence with proton pump inhibitors.
May 2010 ,Medscape Medical News,Management of Serotonin Syndrome Reviewed,"A review for family physicians describes prevention, diagnosis, and management of serotonin syndrome."
May 2010 ,Medscape Medical News,Naltrexone Extended-Release Prescribing Information Strengthened,Naltrexone extended-release injectable suspension has been associated with injection-site reactions based on postmarketing data; the prescribing information has been updated to reflect these data.
April 2010 ,Medscape Medical News,Long-Term Pulmonary Problems After HSCT for Leukemia ,"Hematopoietic stem cell transplantation (HSCT) often cures leukemia, but the grueling treatment can have a long-term adverse effect on the lungs. "
April 2010 ,Medscape Medical News,Risk for Low-Dose Aspirin-Associated Peptic Ulcer Higher in Elderly Women,A study shows sex differences in the clinical features and risk factors for low-dose aspirin-associated peptic ulcer.
July 2010 ,Heartwire from Medscape,Coumadin Samples Recalled in US,"BMS has voluntarily recalled a number of blister packs of Coumadin 1 mg provided as samples in the US, because they may not contain the right amount of an additive, isopropanol. There is little clinical risk from this situation, the company says."
July 2010 ,Medscape Medical News,Iron Dextran Has Highest Adverse Effects Rate of All IV Iron Products,Reported rates of adverse effects from iron dextran in Europe and North America over a 6-year period were much higher than for other intravenous (IV) iron products.
July 2010 ,Medscape Medical News,Psychotropic Medications Linked to Serious Adverse Drug Reactions in Children ,Psychotropic medications were associated with almost 10% of the adverse drug reactions reported in all children in Denmark (from the age of birth to 17 years) between the years 1998 and 2007.
July 2010 ,Medscape Medical News,13 Drugs on Latest FDA List for Safety Monitoring,Physicians should not stop prescribing these medications because the agency has yet to establish a causal relationship with the health risks in question.
July 2010 ,Medscape Medical News,Increased CV Events Halts Testosterone Trial in Older Men,A study to assess testosterone treatment in men 65 years and older who have limitations in mobility has been stopped prematurely because of an increased risk for cardiovascular adverse events.
June 2010 ,Medscape Medical News,Hip Fractures Linked to Thiazolidinedione Use Higher Than Expected in Men,"Fractures associated with the use of rosiglitazone and pioglitazone occur in both women and men; however, middle-aged men have a 2-fold increased risk for hip fracture from thiazolidinedione use."
June 2010 ,Medscape Medical News,Endocrine Society Issues Position Statement on Menopausal Hormone Therapy,"A new Endocrine Society scientific statement evaluates benefits and risks for postmenopausal hormone replacement therapy, now known as menopausal hormone therapy."
June 2010 ,Medscape Medical News,Vaginal Isosorbide Mononitrate Does Not Decrease Time to Vaginal Delivery,The addition of vaginal isosorbide mononitrate to oral misoprostol for cervical ripening and labor induction did not reduce time to vaginal delivery and was associated with a greater incidence of headache.
June 2010 ,Medscape Medical News,Digoxin Use Linked to Mortality in End-Stage Renal Disease,"In a retrospective cohort, digoxin use in patients receiving hemodialysis was associated with increased mortality rates, especially among patients with low predialysis potassium levels."
June 2010 ,Medscape Medical News,"SSRIs, Amantadine May Affect Vision in Elderly","SSRI antidepressants and amantadine have been linked to cataracts and corneal damage, respectively."
June 2010 ,Medscape Medical News,FDA Committee Votes in Favor of Current Safety Monitoring for Most Drugs,The committee to the FDA did not have changes to safety monitoring for any of the drugs evaluated except for desflurane.
June 2010 ,Medscape Medical News,Gemtuzumab Voluntarily Withdrawn From US Market,"Based on discussions with the FDA, Pfizer has announced a voluntary withdrawal of gemtuzumab in the United States. Reasons cited are lack of benefit and safety concerns."
June 2010 ,Medscape Medical News,EPINEPHrine Shortage May Result in Dangerous Medication Errors ,"A shortage of EPINEPHrine prefilled syringes may cause serious medication errors, with 1 death reported from an overdose of EPINEPHrine. "
June 2010 ,Medscape Medical News,Selective COX-2 Inhibitors Cause Less GI Irritation Than NSAID Plus PPI,A selective COX-2 inhibitor provides more gastrointestinal (GI) safety than a nonselective nonsteroidal anti-inflammatory drug (NSAID) plus a proton pump inhibitor (PPI) in patients with arthritis.
June 2010 ,Heartwire from Medscape,Cardiotoxicity Echo Study,Myocardial longitudinal strain and cardiac troponin plasma concentrations may help identify patients in whom anthracyclines and trastuzumab are cardiotoxic.
June 2010 ,Heartwire from Medscape,FDA Conducts Safety Review of Antihypertensive ARB Olmesartan,"There were cautionary signals in two placebo-controlled hypertension trials; still, the agency says, it believes the benefits of the drug, marketed by Daiichi Sankyo as Benicar, ""outweigh its potential risks."" "
June 2010 ,Heartwire from Medscape,"ARBs, Primarily Telmisartan, Linked to 25% Increased Risk of Lung Cancer ","Angiotensin-receptor blockers have been associated with a modest increased risk of developing cancer in a new meta-analysis. Specifically, there was a significant 25% increased risk of lung cancer with these agents. The results, while concerning, must be considered preliminary, say the researchers, who call for the FDA to further examine the issue."
June 2010 ,Heartwire from Medscape,Pfizer Slow to Share Lipitor Adverse Event Reports With FDA,"The 12-page letter documents increasing numbers of adverse-event reports that are not being shared with the FDA within the stipulated 15-day window, including adverse reactions to the company's blockbuster statin, Lipitor. "
June 2010 ,Medscape Medical News,Valproic Acid in Pregnancy Linked to Several Congenital Malformations,A large Swedish observational study confirms link to spina bifida and 5 other malformations.
June 2010 ,Heartwire from Medscape,Interactions With New Anticoagulants,"At present, there are few documented interactions with the new drugs, including dabigatran, rivaroxaban, and apixaban, but considering the extensive food and drug interactions with warfarin, caution should be taken with the new agents, according to researchers."
August 2010 ,Medscape Medical News,"Valproate Reduces 2 Key Proteins, Leading to Bone Loss ","A new study shows that the long-term use of valproate, a drug commonly used to treat epilepsy and bipolar disorder, may decrease the production of both collagen and osteonectin."
August 2010 ,Heartwire from Medscape,Mipomersen in Hypercholesterolemia,"The drug significantly lowered LDL-cholesterol levels in hypercholesterolemia patients, but questions about the drug's effect on the liver are still unanswered. "
August 2010 ,Medscape Medical News,TZDs May Increase Fracture Risk in Postmenopausal Diabetic Women and in Some Men,A study shows that both rosiglitazone and pioglitazone are associated with fractures in postmenopausal women and in a subset of men and that fracture risk is increased with dose.
August 2010 ,Medscape Medical News,Cardiotoxicity of Childhood Cancer Treatments Affects Adult Survivors,"Potentially cardiotoxic cancer treatment during childhood may have long-lasting, subclinical cardiovascular effects in young adults, new research suggests."
August 2010 ,Medscape Medical News,FDA Again Warns Against IV Administration of Nimodipine ,The FDA urges healthcare professionals to advise their patients who spray the drug on their forearm to keep children and pets from coming into contact with the medicated area of skin.
July 2010 ,Medscape Medical News,"Exposure to Estradiol Transdermal Spray Risky for Children and Pets, FDA Says","In 7 cases reviewed by the FDA, patients developed eosinophilic pneumonia 2 to 4 weeks after starting daptomycin treatment. "
July 2010 ,Medscape Medical News,Daptomycin May Be Linked to Eosinophilic Pneumonia,Only newer AEDs with high potential of causing depression were linked to increased suicide risk in a new study.
July 2010 ,Medscape Medical News,Not All Antiepileptics Have Excess Risk for Suicidality ,"Within 3 days after receipt of the diphtheria-tetanus-acellular pertussis vaccine in early childhood, there was no increased risk for seizures."
July 2010 ,Medscape Medical News,DTaP in Early Childhood Not Linked to Increased Seizure Risk Within 3 Days,Enrollment in the controversial study assessing the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone has been stopped at the FDA's request.
July 2010 ,Heartwire from Medscape,TIDE Enrolment Suspended,"Dr David Capuzzi earned $14 750 as a member of the company's speaker's bureau, but received the money related to talks about Lovaza and not for rosiglitazone. Dr Abraham Thomas received a few thousand dollars for speaking on behalf of pioglitazone, Avandia's rival. "
July 2010 ,Heartwire from Medscape,"Capuzzi, Thomas, and Avandia",A joint statement from 3 specialty groups stresses that patients on the controversial medication should keep taking it unless instructed otherwise by their healthcare provider.
July 2010 ,Medscape Medical News,"Patients With Diabetes Have Alternatives to Rosiglitazone, Experts Say","A practical, simple method of identifying elderly inpatients at increased risk for an adverse drug reaction may be useful in clinical practice and in research."
July 2010 ,Medscape Medical News,Simple Tool May Identify Patients at Increased Risk for Adverse Drug Reaction,The US FDA has become the latest regulatory agency to say it will investigate a possible link between angiotensin-receptor blockers and cancer.
July 2010 ,Heartwire from Medscape,US Agency Will Review ARBs for Possible Cancer Risk ,"Near the end of two days of exhaustive, often-polarized debate, 12 panel members said the drug should be withdrawn, with no other choice getting as many votes. But the other 20 votes were spread across three out of four other options, all suggesting that the drug could stay on the market, with certain provisions."
July 2010 ,Heartwire from Medscape,FDA Advisory Committee Sends Mixed Message to FDA,A marathon of 11 hours of presentations has likely left the joint Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees reeling in confusion. Day two promises more time for questions and reflection before the all-important vote.
July 2010 ,Heartwire from Medscape,Day-One Data Deluge at FDA Rosiglitazone Meeting ,More cases of this adverse event prompted the agency to strengthen an existing warning on the label for the rheumatoid arthritis drug.
July 2010 ,Medscape Medical News,FDA Adds Boxed Warning to Leflunomide for Severe Liver Injury,The agency has received reports of gas or air embolisms after the administration of hemostatic drugs and biological products with sprayers pressurized by gas and air.
July 2010 ,Medscape Medical News,"Use Fibrin Sprayers Correctly to Avoid Embolisms, Warns FDA","A new analysis of the ONSET/OFFSET study with ticagrelor, which prospectively assessed the side effect of dyspnea and whether this affected cardiac and pulmonary function, provides reassurance that this adverse effect, while common, is generally mild and self-limiting, say the investigators."
July 2010 ,Heartwire from Medscape,"""Reassuring"" Prospective Data on Dyspnea With Ticagrelor","Treating such cramps with quinine is an off-label use with potentially serious adverse effects, the agency says. "
September 2010 ,Medscape Medical News,FDA May Revise Bisphosphonate Labels in Light of Possible Fracture Risk,A new expert panel report states that clinicians should not prescribe bisphosphonates for patients with a low risk for osteoporosis-related fractures and should consider other drugs for spinal osteoporosis.
September 2010 ,Medscape Medical News,More Evidence Sedatives May Raise Risk of Premature Death,"""Small but significant"" increase in mortality risk seen among anxiolytic and hypnotic drug users in a Canadian study. "
September 2010 ,Heartwire from Medscape,FDA Rosiglitazone Bias?,Two employees of the FDA have raised questions about members of a previous advisory panel who had already voted to keep rosiglitazone on the market being invited to the recent review meeting to decide the future of the drug.
September 2010 ,Medscape Medical News,Optimal Antiemetic Therapy Remains Elusive for Pediatric Cancer Patients,"Data are limited, and information about the most effective antiemetics to prevent chemotherapy-induced nausea and vomiting in children is incomplete and imprecise. "
September 2010 ,Medscape Medical News,Two Hepatitis C Drug Candidates on Hold Because of Adverse Events,"An elevated liver function test for 1 patient appears to be related to gallstones, according to the chief medical officer of Idenix."
September 2010 ,Heartwire from Medscape,British Said Rosiglitazone Should Be Withdrawn; Europeans Discuss,"It has emerged this week that UK experts recommended the withdrawal of the diabetes drug rosiglitazone from the British market in July, although this recommendation was not made public at the time. "
September 2010 ,Medscape Medical News,Use of Postnatal Corticosteroids in Bronchopulmonary Dysplasia Reviewed,The American Academy of Pediatrics has issued a policy statement on use of postnatal corticosteroids to prevent or treat bronchopulmonary dysplasia.
September 2010 ,Medscape Medical News,Sibutramine and Increased Risk for Nonfatal Vascular Events in Preexisting CVD,Subjects with preexisting cardiovascular disease given sibutramine treatment had an increased risk for nonfatal myocardial infarction and nonfatal stroke but not cardiovascular or all-cause death.
September 2010 ,Medscape Medical News,Tigecycline Linked to Increased Mortality Risk,"The increased mortality risk is most evident in patients treated for hospital-acquired pneumonia, and particularly ventilator-associated pneumonia, which is an unapproved indication."
August 2010 ,Reuters Health Information,Several Factors Increase Fracture Risk With Androgen Deprivation for Pro...,A Canadian study has identified several readily available clinical factors that help determine the risk of fractures in men with prostate cancer undergoing androgen deprivation therapy (ADT).
August 2010 ,Medscape Medical News,FDA's Oversight Board Sees Growing Range of Drug Safety Issues,"In the 5 years since the FDA's Drug Safety Oversight Board was formed, the topics discussed have evolved from a single drug or drug class to much broader drug safety issues."
August 2010 ,Medscape Medical News,"Certain Octagam Lots Recalled After Reports of Blood Clots, Embolisms ",The immune globulin G intravenous (human) 5% liquid preparation is used to treat primary immune deficient diseases.
August 2010 ,Heartwire from Medscape,Thiazolidinediones Compared: Comparable CV Risk,"The study isn't a substitute for a bona fide prospective randomized trial, but it is large and controlled for a lot of potential confounders. Why its conclusions contrast with those of some prior studies isn't known for sure, but there's at least one good possible reason. "
August 2010 ,Medscape Medical News,"Acyclovir, Valacyclovir in First Trimester Not Linked to Major Birth Defects","In a large nationwide cohort, use of acyclovir or valacyclovir in the first trimester of pregnancy was not associated with an increased risk for major birth defects."
August 2010 ,Medscape Medical News,EEG Testing May Predict Clozapine Response in Treatment-Resistant Schizophrenia ,"A new pilot study suggests that EEG testing can predict whether patients with treatment-resistant schizophrenia will respond to clozapine, a drug known for its potentially serious adverse effects."
August 2010 ,Heartwire from Medscape,Withdrawal of Midodrine,"The FDA is recommending the withdrawal of midodrine hydrochloride, currently used in the treatment of hypotension, because there are insufficient data to support its benefit. "
August 2010 ,Medscape Medical News,Nebulized 3% Saline Without Bronchodilators May Be Safe for Bronchiolitis,"In a retrospective cohort, nebulized 3% saline solution without adjunctive bronchodilators for inpatients with bronchiolitis had a low rate of adverse events."
August 2010 ,Heartwire from Medscape,Truncated Rimonabant Study Published,"Truncated results from rimonabant's large morbidity and mortality study, a report that editorialists call ""the obituary for a wonder drug,"" are reported this week. The CRESCENDO investigators, however, did not want the trial stopped, but a decision by the EMA tied their clinical hands."
August 2010 ,Medscape Medical News,Acetaminophen Use in Adolescents May Double Risk for Asthma,"A global study shows that acetaminophen use in adolescents is linked to the development and/or maintenance of asthma, rhinoconjunctivitis, and eczema."
August 2010 ,Medscape Medical News,FDA Warns of Aseptic Meningitis Risk With Lamotrigine ,"FDA is warning that lamotrigine (Lamictal, GlaxoSmithKline), approved for treatment of epilepsy and bipolar disorder, can cause aseptic meningitis. "
October 2010 ,Medscape Medical News,Multiple Courses of Antenatal Corticosteroids May Not Improve Outcomes,Multiple courses of prenatal corticosteroids every 14 days did not increase or decrease the risk for death or neurologic impairment at ages 18 to 24 months vs a single course.
October 2010 ,WebMD Health News,FDA Warns Against Over-the-Counter Chelation Treatments,"All over-the-counter chelation treatments are illegal, says the FDA."
October 2010 ,Heartwire from Medscape,FDA Panel to Review Darbepoetin,An early safety review posted online questions the treatment strategy in light of the absence of benefit and increased risk of stroke observed in the TREAT study.
October 2010 ,Heartwire from Medscape,More Heparin Trouble for SPL,Scientific Protein Laboratories has been reprimanded by the US FDA for failing to investigate a complaint about contaminated heparin months after the heparin recalls in 2008.
October 2010 ,Medscape Medical News,FDA Adds Femur Fracture Warning to Bisphosphonate Labels,The label change applies only to bisphosphonates approved for the treatment of osteoporosis.
October 2010 ,Heartwire from Medscape,Atorvastatin Recall ,"Pfizer has recalled seven lots of atorvastatin (Lipitor) because of an ""uncharacteristic odor related to the bottles in which the product is packaged"". "
October 2010 ,Medscape Medical News,Abbott Withdraws Sibutramine From Market,The US FDA asked the manufacturer to pull the weight-loss medication from the market after clinical trial data pointed to a 16% increase in the risk for serious cardiovascular events.
October 2010 ,Heartwire from Medscape,COGENT Published,Patients on dual antiplatelet therapy had a significant reduction in GI events with omeprazole and no increase in cardiovascular events in the first randomized trial of PPI use with clopidogrel. And a new mechanistic study suggests that the clopidogrel-omeprazole interaction may be dose dependent.
October 2010 ,Medscape Medical News,New Discipline of Cardioncology Evolves as Cancer Patients Live Longer ,Growing awareness about the cardiovascular adverse effects of novel anticancer drugs has given birth to a new discipline of cardioncology.
October 2010 ,Heartwire from Medscape,FDA Deputy on Rosiglitazone,"Dr Joshua Sharfstein, principal deputy commissioner of the FDA, discusses the recent FDA decision to allow Avandia to stay on the market with restricted access and compares the decision with the European approach that suspended the drug."
October 2010 ,Medscape Medical News,Caffeine Intake During Pregnancy Not Linked to Risk for Preterm Birth,A meta-analysis of cohort and case-control studies shows no important association between caffeine intake during pregnancy and the risk for preterm birth.
October 2010 ,Medscape Medical News,Medications for Insomnia or Anxiety Linked to 36% Increase in Mortality Risk,"Because sedative drug use is associated with a 36% increase in mortality risk, physicians should consider nonpharmacologic treatment options for insomnia or anxiety."
September 2010 ,Medscape Medical News,Lots of Epogen and Procrit Recalled Due to Glass Flakes in Vials,"Several lots epoetin alfa vials are subject to recall, according to an FDA alert. "
September 2010 ,Medscape Medical News,PPIs After MI Linked to Increased Risk for Adverse Cardiovascular Outcomes,"Proton pump inhibitors are associated with an increased risk for adverse cardiovascular outcomes after discharge in patients with myocardial infarction, regardless of clopidogrel use."
September 2010 ,Heartwire from Medscape,"Reaction to Rosiglitazone Decisions Mixed, But Measured","Diabetes doctors convened at the EASD meeting in Stockholm have given their verdict on the differing decisions made by the European and American regulatory authorities yesterday on the fate of rosiglitazone. In the US, Nissen says he is ""pleased"" by the EMA actions; the FDA moves are ""reasonable,"" he added. "
September 2010 ,Heartwire from Medscape,"FDA Restricts Rosiglitazone, But EMA Suspends It ","After months of deliberations, the FDA has opted to allow Avandia to stay on the market, but only with severe restrictions. It also opted to stop the TIDE trial, pending a rereview of the RECORD trial. In contrast, the EMA has ordered the suspension of all rosiglitazone-containing products"
September 2010 ,Heartwire from Medscape,Clopidogrel-PPI: Mechanistic Studies ,"But cardiologists continue to debate whether these results, which show a definite interaction, are clinically relevant. "
September 2010 ,Medscape Medical News,FDA Studying Possible Link Between Pioglitazone and Bladder Cancer,"Study of 193,000 Kaiser patients shows increased risk after 24 months of treatment, but the agency has not reached any conclusions about causation. "
September 2010 ,Heartwire from Medscape,Sibutramine Risks Warrant Restrictions or Withdrawal: FDA Panel ,"Six members of the FDA panel voted to recommend that the FDA severely restrict access to the weight-loss drug, and eight recommended the plug be pulled on it altogether. Only two on the panel reviewing the SCOUT trial concluded that the drug should remain on the market with a boxed warning only, and no members thought the drug could stay with no labeling changes. "
September 2010 ,Medscape Medical News,Hormonal Analog Reduces Visceral Adipose Tissue in HIV-Infected Patients,"A pooled analysis of 2 phase 3 trials shows benefits of tesamorelin across subgroups of HIV-positive patients, including sex, race, and varying disease characteristics."
November 2010 ,Heartwire from Medscape,"Benfluorex, Hospitalizations, Deaths, Valvular Disease","The drug, available in just a handful of countries, is also used off-label to treat obesity. A new report links it to at least 500 deaths and at least 3500 hospitalizations in France."
November 2010 ,Heartwire from Medscape,APPRAISE-2 Halted,"The move will include all propoxyphene-containing products, both brand-name and generic."
November 2010 ,Medscape Medical News,Propoxyphene Withdrawn From US Market,This brings the total number of cases to 75.
November 2010 ,Medscape Medical News,Biogen Reports 5 New Cases of PML With Natalizumab ,"Looking back, historians may mark 2010 as the most significant year for US medicine in decades."
November 2010 ,Medscape Medical News,Top 10 Medical News Stories of 2010,The US Department of Health and Human Services Office of Inspector General recommends that the Medicare program expand the list of adverse events for which it will not foot the bill.
November 2010 ,Medscape Medical News,Nearly 1 in 7 Hospitalized Medicare Patients Experience Adverse Events ,"In a study of healthy older men, dihydrotestosterone treatment for 24 months did not affect prostate growth but caused a decrease in spinal, but not hip, bone mineral density."
November 2010 ,Medscape Medical News,Dihydrotestosterone May Not Affect Prostate Growth But May Reduce BMD,Children are more likely than adults to be positive to amoxicillin on penicillin skin testing.
November 2010 ,Medscape Medical News,Kids More Likely to Show Allergy to Amoxicillin Than Adults,Studies comparing topical and oral diclofenac for the treatment of knee osteoarthritis showed comparable efficacy and fewer adverse effects with the topical formulation.
November 2010 ,Medscape Medical News,"Topical vs Oral Diclofenac: Equal Efficacy, Fewer Adverse Effects","Aromatase inhibitors are powerful medicine for postmenopausal women with breast cancer, but they also have a lot of adverse effects."
November 2010 ,Medscape Medical News,"Aromatase Inhibitor Adverse Effects Are Like ""Menopause Plus""","A quarterly publication from the nonprofit Institute for Safe Medicine Practices has aired safety issues with Multaq, approved recently for atrial fibrillation, and questions its ""suitability for widespread use."""
November 2010 ,Heartwire from Medscape,ISMP Report Questions Multaq Safety,The document recommends the use of proton-pump inhibitors in patients taking thienopyridine antiplatelet agents at high risk of GI bleeding but not in those at low risk; exactly how to define high- and low-risk patients is left to the individual physician.
November 2010 ,Heartwire from Medscape,PPIs and Antiplatelets: Consensus,"A joint panel of FDA experts has voted unanimously in favor of keeping intravenous phenytoin on the market, despite known serious adverse effects, such as purple glove syndrome."
November 2010 ,Medscape Medical News,"Phenytoin Injection Should Stay on the Market, FDA Panels Recommend","A new meta-analysis shows that the incidence of cough occurring with ACE inhibitors is almost 10-fold higher than is stated in the drugs' labels or in the Physicians' Desk Reference. The findings are cause for concern, given that this underreporting could also be happening with more severe side effects, say the researchers; they call for the updating of drug labels to become mandatory."
November 2010 ,Heartwire from Medscape,Nuisance Side-Effect Underreported in Label; Implications Are Important ,"A California heparin manufacturer, supplied by a company that played a role in the worldwide 2008 heparin recall, has announced a new recall that so far involves only seven lots of the product."
November 2010 ,Heartwire from Medscape,"SPL, B Braun Medical in New Heparin Recall","The MedWatch drug safety surveillance program is passive and reactive, underutilized, and does not contain enough detail; FDA's Surveillance Initiative is intended to correct this."
November 2010 ,Medscape Medical News,Drug Safety Surveillance,"The contaminated antimetabolite could trigger a variety of serious adverse events, depending on the kind of parenteral administration. "
October 2010 ,Medscape Medical News,Sandoz Recalls Methotrexate Vials That May Contain Glass Flakes,Eighteen lots of fentanyl transdermal 25 mcg/hour patches are subject to voluntary recall because of the accelerated release of fentanyl in 1 patch.
October 2010 ,Medscape Medical News,Fentanyl Transdermal System Lots Recalled,The FDA is advising clinicians to perform an electrocradiogram before starting patients on saquinavir combined with ritonavir.
October 2010 ,Medscape Medical News,New Warning of Cardiac Risk Added to Saquinavir Label,"Patients receiving GnRH agonists may be at a ""small increased risk"" for diabetes, heart attack, stroke, and sudden death."
January 2011 ,Medscape Medical News,"Humanized Monoclonal Antibody May Be Effective, Safe in Asthma Patients","In a systematic review, add-on therapy with a subcutaneous humanized monoclonal antibody was safe and effective in patients with moderate to severe allergic asthma."
January 2011 ,Medscape Medical News,Fatal Medication Errors Seen With High-Dose Morphine Oral Solution,"Due to reports of serious adverse events and deaths, labeling and packaging for high-potency morphine sulfate oral solution have been revised."
January 2011 ,Reuters Health Information,First-in-Class Antibiotic Has High Risk of Adverse Events and Death,"Despite the similar efficacy with comparator drugs, tigecycline was associated with an increased incidence of all adverse events, especially those involving the digestive system."
January 2011 ,Medscape Medical News,Bevacizumab Increases Heart Failure in Patients With Breast Cancer,Yet another adverse effect has been reported for bevacizumab in the treatment of advanced breast cancer -- congestive heart failure.
December 2010 ,Medscape Medical News,"Complementary, Alternative Medicine Linked to Adverse Events in Children","A surveillance study shows that complementary and alternative medicine, especially when associated with failure to use conventional medicine, can lead to serious and fatal adverse events in children."
December 2010 ,Medscape Medical News,FDA Warns of Possible Increased Risk for Death With Somatropin,A long-term follow-up study from France hints at a possible increased risk for death in people treated with the recombinant human growth hormone somatropin during childhood.
December 2010 ,WebMD Health News,FDA Targets Tainted Dietary Supplements,The FDA warns supplement industry and launches a new system to notify consumers.
December 2010 ,Medscape Medical News,FDA Warns Against Injection Dolasetron Due to Risk for Heart Arrhythmias,"Because of heart rhythm abnormalities, the FDA recommends no longer using the injectable form of dolasetron mesylate for chemotherapy-induced nausea and vomiting. "
December 2010 ,Medscape Medical News,Candy-Like Cough Capsules May Pose Serious Risk to Young Children,The FDA reports 7 cases of accidental ingestion associated with benzonatate (Tessalon) in children younger than 10 years.
December 2010 ,Heartwire from Medscape,Rofecoxib Risks Confirmed to Last at Least a Year After Discontinuation,A new analysis of the only other study known to have continued to follow outcomes in patients once they had stopped taking the COX-2 inhibitor rofecoxib confirms that a doubling of cardiovascular risk persisted in those who took the drug for at least a year after stopping therapy.
December 2010 ,Heartwire from Medscape,Stopping CRESCENDO Early,"One group argues that the trial was stopped too late, noting that the adverse psychiatric profile of the drug was raised as early as 2006, months before CRESCENDO even began, while another researcher wonders whether or not genetic testing might have identified patients taking rimonabant who were at risk for suicide."
December 2010 ,Heartwire from Medscape,Pfizer Pulls PAH Drug Due to Liver Toxicity,"Pfizer announced today that it will voluntarily withdraw sitaxentan, a drug for pulmonary arterial hypertension, following two cases of fatal liver toxicity."
December 2010 ,Medscape Medical News,Osteoporosis Risk With Asthma and COPD Therapies Needs More Vigilance,"For patients with asthma and chronic obstructive pulmonary disease (COPD) who are taking therapies that pose a risk for osteoporosis, screening might help prevent irreversible bone loss."
December 2010 ,Heartwire from Medscape,FDA Advisors Mostly Positive on Naltrexone/Bupropion Diet Drug,"In all, 13 panel members voted ""yes"" to the question of whether the potential benefits of naltrexone/bupropion outweigh its potential risks if used long term, while seven voted ""no."" On a separate question, eight voted to recommend that a cardiovascular outcomes study be conducted prior to drug approval, while 11 voted that such a study could happen postapproval."
December 2010 ,Medscape Medical News,Escalated BEACOPP Superior to ABDV in Early Hodgkin's Lymphoma,"The more aggressive chemotherapy regimen gave better overall tumor control, but at the cost of greater toxicity and no survival difference. "
December 2010 ,WebMD Health News,Invisalign 'Invisible Braces' Maker Gets FDA Warning,"Adverse events were not reported to the agency, the FDA says."
November 2010 ,Heartwire from Medscape,"New Review Reassures on ARB/Cancer Risk, But Questions Linger","A new meta-analysis has found no increased risk of cancer or cancer death with any antihypertensive drug, including angiotensin receptor blockers, countering the conclusions of another review published earlier this year. However, the new paper did find an increased cancer risk with the combination of ARB plus ACE inhibitor, so questions still remain. Regulatory agencies are currently reviewing the"
November 2010 ,Medscape Medical News,Therapeutic Acetaminophen Not Linked to Liver Injury in Children,A systematic review shows that hepatoxicity after therapeutic dosing of acetaminophen in children is rarely reported in defined-population studies.
November 2010 ,Medscape Medical News,First-Trimester PPI Use May Not Significantly Increase Risk for Birth Defects,"In a large cohort, exposure to proton-pump inhibitors during the month before conception, but not during the first trimester, was associated with a significantly increased risk for major birth defects."
November 2010 ,Medscape Medical News,Grass Allergy Immunotherapy Tablet Shows Promise for Children,A grass allergy immunotherapy tablet is effective and safe in children 5 years and older.
February 2011 ,Medscape Medical News,Hydrocodone Bitartrate/Acetaminophen and Phenobarbital Tablets Recalled,"Mislabeled bottles may result in patients unintentionally taking one product instead of the other, with potentially serious harm. "
February 2011 ,Medscape Medical News,Bevacizumab Linked to Fatal Adverse Effects in Cancer Patients,A meta-analysis shows that this cancer drug may be associated with an increased risk for treatment-related death.
February 2011 ,Heartwire from Medscape,Contrave Naltrexone/Bupropion Sent Back for CVD Study,"The drug, a combination of naltrexone and bupropion HCL, had been given a positive decision by the majority of members on an FDA advisory group panel in December."
January 2011 ,Medscape Medical News,Drug-Induced Deaths More Common Than Alcohol- or Firearm-Related Fatalities,"A new report from the CDC finds rates of drug-induced deaths are significantly higher for males than females, especially for non-Hispanic white and black males."
January 2011 ,Heartwire from Medscape,FAST-MI Registry on Clopidogrel-PPI Interaction,"The observation was independent of whether patients carried a gene variant also associated with reduced clopidogrel effectiveness. The findings add yet more observational data to a debate that really could use a solid prospective, randomized trial."
January 2011 ,Medscape Medical News,Vinorelbine 'Preferred' Chemo in HER2-Positive Advanced Breast Cancer,"Vinorelbine is not more effective than a taxane, according to a new phase 3 study, but it does have a better toxicity profile."
January 2011 ,Heartwire from Medscape,ACE Inhibitors Rather Than ARBs Could Save Can$20 Million Per Year,"Restricting the prescribing of angiotensin-receptor blockers so that they are given only to patients who are intolerant to ACE inhibitors--as is done in one Canadian province--could save millions of dollars in costs without any adverse effects on cardiovascular health, say the authors of a new paper. But this assumes equivalence of the two drug classes, which is not yet proven, says one observer."
January 2011 ,Medscape Medical News,Risk for Death After Trauma Higher in Patients Using Warfarin,"Warfarin use is associated with a significant increase in death among injured patients, even after adjustment for confounding comorbidities."
January 2011 ,Heartwire from Medscape,Choose Azithromycin as a Macrolide if Patient Is on a CCB,"Doctors need to be aware of an underappreciated risk of hypotension associated with the use of calcium-channel blockers together with macrolide antibiotics such as erythromycin and clarithromycin, Canadian researchers say. If a macrolide-type antibiotic is needed, azithromycin--which does not increase the risk of hypotension--is a better choice, they state."
January 2011 ,Medscape Medical News,Steroid-Dopamine Combination May Be Fatal in Septic Shock,"Steroids plus dopamine therapy are linked to increased mortality in patients with shock, especially those with septic shock."
January 2011 ,Medscape Medical News,Propofol Infusion Syndrome Real but Rare,Propofol infusion syndrome is a real but rare entity that can be completely prevented with a simple protocol.
January 2011 ,Heartwire from Medscape,EMA Also Wants Liver Warnings Added to Dronedarone Labeling,"Following in the footsteps of action taken in the US last week, the European Medicines Agency says urgent changes need to be made to the product information for dronedarone, indicating a possible association with liver complications."
January 2011 ,Reuters Health Information,Sarkozy Vows Health System Fix After Drug Furor,French President Nicolas Sarkozy pledged on Thursday to shake up the healthcare system and root out fraud after a report said a drug suspected of killing more than 500 people should have been pulled years before it was.
January 2011 ,Medscape Medical News,IMRT for Anal Cancer Associated With Fewer Adverse Events,"Without affecting 2-year outcomes, intensity-modulated radiation therapy (IMRT) had fewer adverse events than conventional radiation therapy. "
January 2011 ,WebMD Health News,Tylenol Products Recalled,The products were made at facility where cleaning procedures were insufficient or not adequately documented.
January 2011 ,Reuters Health Information,Few Women With RA Use Contraindicated Drugs During Pregnancy,"Only a small minority of women with rheumatoid arthritis are prescribed drugs that are contraindicated during pregnancy, but those who do take them have higher rates of spontaneous abortion."
January 2011 ,Heartwire from Medscape,"Dronedarone Linked to Liver Damage, Transplants, Says Sanofi","Sanofi Aventis has sent out a letter to US healthcare professionals alerting them to an association between severe hepatic injury, including two liver transplants, and use of its anti-arrhythmic drug, dronedarone (Multaq). The company says it will also change the prescribing information for the product, although it stresses no causal association has yet been established. The FDA has also issued a "
January 2011 ,Medscape Medical News,FDA Still Evaluating Insulin Glargine and Possible Cancer Risk,"The evidence showing an increased cancer risk associated with insulin glargine remains inconclusive, but the FDA is continuing its safety review of the product. "
January 2011 ,Medscape Medical News,Tuberculosis Therapy in Older Patients Linked to Increased Adverse Events,The risk for adverse events requiring hospitalization was significantly increased in patients older than 65 years receiving treatment of latent tuberculosis infection.
January 2011 ,Medscape Medical News,Early Antibiotic Use Linked to Asthma and Allergy at Age 6 Years,A cohort study shows that antibiotic use by age 6 months is associated with asthma and allergy at age 6 years and that protopathic bias is unlikely to explain the main findings.
March 2011 ,Medscape Medical News,Fish Oil Helps Prevent Weight and Muscle Loss in Cancer Patients,Fish oil supplementation might prevent the muscle and weight loss that commonly occurs in cancer patients during chemotherapy.
March 2011 ,Medscape Medical News,"Abacavir Does Not Raise MI Risk, FDA Analysis Shows",Conflicting information about abacavir's myocardial infarction risk prompted the FDA to study 26 clinical trials involving the drug in HIV-infected patients.
March 2011 ,Medscape Medical News,Some Immune-Modifying Biologics Are Safer Than Others,Patients taking immune-modulating biologics are also likely to experience adverse effects and tuberculosis reactivation vs patients receiving placebo.
February 2011 ,Medscape Medical News,"Coadministration of Flu, Pneumococcal Vaccines Linked to Febrile Seizures",CDC's Advisory Committee on Immunization Practices (ACIP) discusses febrile seizures associated with vaccine use.
February 2011 ,Reuters Health Information,Negative Drug Rechallenge After Skin Reaction Predicts Long-Term Tolerance,A French study shows that patients with skin reactions to drugs who do not react to a rechallenge will likely exhibit tolerance to the drugs during the long term.
February 2011 ,Heartwire from Medscape,"Congress Slams FDA Over Heparin Saga, Again","Representatives of the House Energy and Commerce committee are asking the agency to supply documents relating to the investigation and tests, to be delivered within two weeks."
February 2011 ,Medscape Medical News,New Details on Osteonecrosis Risk With Bisphosphonates,Two new studies report an association between bisphosphonate use and osteonecrosis of the jaw.
February 2011 ,Medscape Medical News,High Court Protects Vaccine Makers for 'Unavoidable' Adverse Events,"Parents still have recourse through the federally mandated ""Vaccine Court."""
February 2011 ,Medscape Medical News,Long-Term Use of Bisphosphonates Increases Risk for Atypical Fractures,"Among older women, treatment with a bisphosphonate for more than 5 years was linked to an increased risk, but a low absolute risk, for subtrochanteric or femoral shaft fractures."
February 2011 ,Medscape Medical News,Risks With Antipsychotics in Pregnancy Stressed in New Label ,Taking these medications during the third trimester of pregnancy puts neonates at risk for abnormal muscle movements and withdrawal symptoms.
February 2011 ,Medscape Medical News,Bleomycin Being Underdosed in Advanced Germ Cell Tumors?,A study of bleomycin toxicity showed that asymptomatic drops in lung function scores caused 20% of bleomycin doses to be missed and 20% of patients to receive less than their planned doses.
February 2011 ,Medscape Medical News,Boxed Warnings Not Ordered Systematically,"Within a given drug class, 1 agent may have a boxed warning, but others may not. The FDA should require the labels of same-class drugs without warnings to explain this omission."
February 2011 ,Heartwire from Medscape,"Lots of Jantoven, other agents recalled",Upsher-Smith has expanded its recall from one lot to 16 lots of its Jantoven brand of warfarin sodium and has added lots of amlodipine and other drugs.
February 2011 ,Medscape Medical News,Advantage to Radiation Plus Chemo in Hodgkin's Lymphoma,"Despite concerns about serious long-term effects, a meta-analysis found a clear advantage to giving both radiation and chemotherapy, compared with chemotherapy alone."
February 2011 ,Medscape Medical News,Acid-Suppressive Medication Not Preferred Treatment Outside ICU,"Although acid-suppressive medication protected against nosocomial gastrointestinal tract bleeding, the number needed to treat to prevent 1 case was relatively high."
February 2011 ,Medscape Medical News,PPI Use May Reduce Antifracture Efficacy of Bisphosphonate Treatment,"In an observational study, concurrent proton-pump inhibitor use was associated with a dose-dependent loss of protection against hip fracture treatment in elderly patients."
February 2011 ,Reuters Health Information,NSAIDs May Worsen Pneumonia Outcomes,The benefits of nonsteroidal anti-inflammatory drugs in the treatment of lower respiratory tract infection may be outweighed by a delayed diagnosis of community-acquired pneumonia.
February 2011 ,Medscape Medical News,Risk for Local Reaction to Fifth Dose of DTap Vaccine Higher With Arm Injection,Risk for a local reaction to the fifth dose of the diphtheria and tetanus toxoids and acellular pertussis vaccine is significantly higher when it is injected in the arm.
February 2011 ,Medscape Medical News,FDA Adds 13 Drugs to Watch List,A drug's appearance on the FDA's watch list does not mean the agency has concluded it necessarily triggers the adverse event in question.
February 2011 ,Heartwire from Medscape,New Rosiglitazone Label,"The new label has been changed to highlight the increased cardiovascular risks with the drug, noting that in a meta-analysis of 52 studies, most of which compared rosiglitazone with placebo, the drug was associated with a significantly increased risk of MI."
April 2011 ,Medscape Medical News,Targeting 2 Pathways May Enhance Antitumor Activity,Combining therapies that target MEK and PI3K pathways has the potential to be more effective than either agent used alone.
March 2011 ,WebMD Health News,Johnson & Johnson Recalls Even More Tylenol,One lot of Tylenol 8-Hour Extended Release caplets is the latest recall.
March 2011 ,Medscape Medical News,An Antidepressant Reduces the Neurotoxicity of Oxaliplatin,New findings might have immediate clinical applications.
March 2011 ,Medscape Medical News,BMD Decreases After Bariatric Surgery in Adolescents,"Within 2 years of surgery, bone mineral density levels do not decrease below average for age and sex, but if bone loss continues, it could have long-term consequences."
March 2011 ,Medscape Medical News,Some Bottles of Citalopram Recalled Due to Mislabeling,"Certain bottles of the antidepressant citalopram are being recalled because they may actually contain finasteride, which is associated with possible severe side effects in pregnant women."
March 2011 ,Heartwire from Medscape,ARB/ACE-Inhibitor Combo a Risk in Clinical Practice,Combining the two types of agent has increased the risk of renal dysfunction in clinical trials; the way the drugs are combined in clinical practice doesn't seem to avoid the problem.
March 2011 ,Medscape Medical News,Risk Allele Flags Carbamazepine Hypersensitivity in Europeans,The researchers say adding association of HLA-A*3101 to carbamazepine reactions to the drug label should be considered.
March 2011 ,Medscape Medical News,Fracture Warning Nixed for OTC Proton Pump Inhibitors,"Clinicians, however, should remember the possible risk of bone fracture if they advise patients to take an OTC proton pump inhibitor at higher doses or for longer periods than the label calls for."
March 2011 ,Heartwire from Medscape,Adding Therapies to Aspirin Increases Risk of GI Bleeds,"New figures from a UK primary care database confirm that use of clopidogrel, warfarin, NSAIDs or high-dose corticosteroids on top of low-dose aspirin further increase the risk of gastrointestinal bleeding. And the study is one of few to quantify this risk, say the researchers."
March 2011 ,Heartwire from Medscape,More Damning Data on Rosiglitazone,"A new meta-analysis of observational studies shows rosiglitazone to be associated with a higher risk of heart failure, MI, and death than pioglitazone. But despite having been taken off the market in Europe, the REMS restriction for rosiglitazone recommended by the US FDA last September has still not been finalized."
March 2011 ,Medscape Medical News,American Regent Recalls 2 Lots of Sodium Chloride Injection ,Two lots of concentrated sodium chloride Injection are being voluntarily recalled because of particulate matter.
March 2011 ,Medscape Medical News,Morphine/Naltrexone Combo Temporarily Withdrawn,"King Pharmaceuticals notes that Embeda, a combination of morphine and naltrexone, has been voluntarily withdrawn because ""a prespecified stability requirement was not met during routine testing."""
March 2011 ,Medscape Medical News,Analysis Clarifies Drug Choices for People With Type 2 Diabetes,"In a new analysis, the evidence supports the choice of metformin as first-line therapy but also finds that the long-term benefits and harms of diabetes medications remain unclear."
March 2011 ,Heartwire from Medscape,PPIs and Clopidogrel: New Theory May Explain CV Risk Signal,Authors of yet another analysis trying to get to the bottom of the real or perceived risk of combining clopidogrel with a proton-pump inhibitor have a new and provocative theory as to just where the signal of increased events may be coming from.
March 2011 ,Medscape Medical News,FDA: Avoid Use of Kaletra Oral Solution in Newborns,"Kaletra oral solution should be avoided in premature or full-term infants for the first 14 days after their due dates because of possible cardiac, renal, or respiratory problems."
March 2011 ,Reuters Health Information,"Japan Halts Prevenar, ActHIB Vaccines After Four Children Die",Japan's health ministry has halted the use of vaccines made by Pfizer Inc and Sanofi-Aventis SA to prevent meningitis and pneumonia following the deaths of four children.
March 2011 ,Medscape Medical News,Regular NSAID Use Linked to Erectile Dysfunction,Regular use of nonsteroidal anti-inflammatory drugs is associated with erectile dysfunction beyond what would be expected because of age and comorbidity.
March 2011 ,Reuters Health Information,"When Birth Control Pills Are OTC, Patient Education Is Crucial","American women are crossing the border to buy over-the-counter birth control pills in Mexico, often without realizing when they have contraindications to the pills, researchers say."
March 2011 ,WebMD Health News,Drug-Related Poisonings Land Many in ER,"Emergency departments treat an estimated 700,000 people yearly for drug poisonings, including many children."
March 2011 ,Medscape Medical News,"FDA Pulls Unapproved Cold, Cough, Allergy Drugs From Market",The US Food and Drug Administration is requiring a halt to the manufacture and distribution of certain unapproved prescription oral agents.
May 2011 ,Medscape Medical News,Genetic Biomarkers May Predict Taxane-Induced Neuropathy,Several single-nucleotide polymorphisms associated with time to neuropathy in patients receiving paclitaxel therapy have been identified.
May 2011 ,WebMD Health News,Correct Acetaminophen Dose Depends on Children's Weight,Infant drug labels should spell out dose.
May 2011 ,Reuters Health Information,Zoledronic Acid Linked With Seizures in Case Reports,"Use of zoledronic acid for osteoporosis may occasionally be associated with seizures, according to three case reports published online April 20th in the Journal of Clinical Endocrinology & Metabolism."
May 2011 ,Medscape Medical News,Vaccine Critics Claim Court Paid for Autism Cases,The study reports that 83 cases of vaccine-caused brain damage receiving federal compensation involved autism. Experts reply that shared symptoms do not make brain damage and autism identical.
May 2011 ,Medscape Medical News,Absolute Risk for Femur Fracture Low With Bisphosphonates,"Although there is a high rate of bisphosphonate use among patients with atypical femur fractures, the absolute risk for such fractures is small enough to justify prescribing the drugs."
May 2011 ,Medscape Medical News,Thyroid Drug Linked to Fracture Risk in Older Adults,"Among adults 70 years and older, current thyroid treatment was associated with significantly increased fracture risk, with a strong dose-response relationship."
April 2011 ,Reuters Health Information,FDA: Safety Issue With Investigational Merck Hepatitis Drug,"U.S. drug reviewers highlighted safety issues with an experimental Merck & Co hepatitis drug, including anemia and reports of psychiatric problems, in documents released on Monday."
April 2011 ,Medscape Medical News,FDA Adds Further Risk Information to Natalizumab Label ,The FDA identified a need to better define risk for progressive multifocal leukoencephalopathy and increased risk from concomitant immunosuppressants.
April 2011 ,Medscape Medical News,Nine Drugs Added to FDA Watch List,A drug's appearance on the watch list does not mean the agency has determined that the drug necessarily causes the adverse event in question.
April 2011 ,Reuters Health Information,More Evidence That Gastric Acid-Suppressive Drugs Raise Pneumonia Risk,"A new study shows that proton pump inhibitors are linked to a higher risk for community-acquired pneumonia, although the underlying mechanism remains unclear."
April 2011 ,Medscape Medical News,Paracetamol Use in Pregnancy Linked to Childhood Asthma,A meta-analysis of studies shows a 21% increase in the risk for childhood asthma associated with use of paracetamol at any time during pregnancy.
April 2011 ,Medscape Medical News,New vs Old Contraceptives Have Similar Gallbladder Disease Risk,"The risk for gallbladder disease is virtually the same with newer and older types of birth control pills, according to a comparative safety study."
April 2011 ,Heartwire from Medscape,"Diet Drug Orlistat Linked to Kidney, Pancreas Injuries","A review of patients taking the diet drug orlistat over a seven-year period points to a 2% increase in acute kidney injuries within one year of patients starting the drug. Separately, safety-watchdog Public Citizen is once again petitioning the FDA to remove the drug from the market, citing adverse-event reports."
April 2011 ,Heartwire from Medscape,EMA Warns of Hypersensitivity Reactions With Prasugrel,"The risks of hypersensitivity reactions are considered ""uncommon,"" affecting anywhere from 0.1% to 1.0% of patients treated with prasugrel."
April 2011 ,Medscape Medical News,FDA Investigating Cancer Risk With Lenalidomide ,"Lenalidomide (Revlimid) may be associated with an increased risk for certain forms of hematologic malignancies, according to the FDA."
April 2011 ,Medscape Medical News,"Ipilimumab Is for Community-Based Oncologists Too, Says Expert","It's the first-ever drug to be proven to extend survival in advanced melanoma, and it has life-threatening adverse events."
April 2011 ,Medscape Medical News,Topical Benzocaine Associated With Methemoglobinemia,"Benzocaine sprays, gels, and liquids may cause methemoglobinemia, a rare but serious and potentially fatal condition."
April 2011 ,Medscape Medical News,Ipilimumab Risk Strategy Released by FDA,A risk evaluation and mitigation strategy informs healthcare professionals of the serious risks associated with newly approved ipilimumab and recommended management strategies.
April 2011 ,Medscape Medical News,Risks of Estrogen Therapy May Change With Longer Follow-Up,"At 10.7-year follow-up of postmenopausal women with prior hysterectomy and estrogen therapy (median, 5.9 years), breast cancer risk was still decreased and other shorter-term risks had lessened."
April 2011 ,Medscape Medical News,Neck Circumference Linked to Perioperative Respiratory Events,High neck circumference could potentially be used to screen children for the risk for perioperative adverse respiratory events.
June 2011 ,WebMD Health News,New Tylenol Recall Due to Musty Odor,"Johnson and Johnson recalls about 60,000 bottles of Tylenol Extra Strength Caplets."
June 2011 ,Medscape Medical News,"Recall of Pain, Headache Meds Because of Label Mix-Up","Patients who accidentally take a tablet containing butalbital could experience sedation, lightheadedness, dizziness, and nausea, according to the US Food and Drug Administration."
June 2011 ,Heartwire from Medscape,Study Raises Cancer-ARB Question Again,"In this latest study of diabetic patients treated with ARBs, candesartan was associated with a significant risk of cancer, while there was a trend toward an increased risk with telmisartan. The clinician who first sparked the ARB-cancer controversy says these new data should force the FDA to look again at patient-level data to assess the cancer risk with the drug class."
June 2011 ,Medscape Medical News,Risperidone Recalled Due to Possible Contamination ,"Manufacturers of the antipsychotic risperidone have initiated a voluntary recall involving 40,000 bottles of the drug due to possible contamination with a wood preservative. "
June 2011 ,Medscape Medical News,Acute Myeloid Leukemia Patients Overdosed With Cytarabine,"Patients being treated for acute myeloid leukemia receive up to 10 times more cytarabine than necessary, exposing them to excess toxicity but no added efficacy."
June 2011 ,Heartwire from Medscape,Pioglitazone for 1 Year May Increase Risk of Bladder Cancer,"In the FDA's announcement today, the agency stated that information on the drug's label, as well as the patient medication guide, will be revised to include this new information."
June 2011 ,Medscape Medical News,New Criteria Define Inappropriate Meds in Older Inpatients,STOPP criteria define potentially inappropriate medications and are significantly associated with avoidable adverse drug events leading to urgent hospitalization in older persons.
June 2011 ,Medscape Medical News,Electronic Postdischarge Chart Prevents Adverse Drug Events,"Hospitalized patients who are receiving high-risk medications such as warfarin, analgesics, or benzodiazepines benefit from having pharmacists involved in discharge planning."
June 2011 ,Medscape Medical News,Long-Term Doxorubicin Linked to Secondary Oral Cancers,Secondary cancers of the oral cavity appear to be associated with long-term treatment with pegylated liposomal doxorubicin in patients with recurrent ovarian cancer.
June 2011 ,Heartwire from Medscape,French Regulators Suspend Pioglitazone Citing Cancer Risk,"The decision to yank the drug was made after a study requested by the drug regulatory authority, AFSSAPS, confirmed a small increase in bladder cancer among patients treated with the diabetes drug."
June 2011 ,Medscape Medical News,Toxidromes: What Every Critical Care Nurse Should Know,"Critical care nurses need to be aware of toxidromes, a group of signs and symptoms and/or characteristic effects associated with exposure to a particular substance or class of substances."
June 2011 ,Medscape Medical News,Drug Product Recall Due to Possible Penicillin Contamination ,Concerns over potential cross-contamination of nonpenicillin drug products with penicillin have resulted in a nationwide recall of multiple repackaged products.
June 2011 ,Heartwire from Medscape,FDA Review Concludes: No Cancer Risk With ARBs,"An FDA review launched in the wake of a controversial 2010 meta-analysis has concluded that the drugs do not pose a cancer risk to patients. The FDA says it conducted a much larger, more comprehensive review of the data to reach its reassuring conclusions. Not everyone, however, is satisfied."
May 2011 ,Medscape Medical News,Sulfonamides and Nitrofurantoins OK to Use During Pregnancy,An opinion statement says that most antibiotics are safe to use during pregnancy and that pregnant women should not be denied appropriate treatment of infections.
May 2011 ,Medscape Medical News,Adverse Device-Related Events Are Frequent in Children,Adverse outcomes from the use of medical devices in children are frequent but underrecognized.
May 2011 ,Medscape Medical News,Daily Azithromycin Reduces Acute Exacerbations of COPD,A systematic review suggests that antibiotic exposure prenatally or in early childhood may slightly increase the risk for childhood asthma.
May 2011 ,Medscape Medical News,Antibiotics May Slightly Increase Risk for Childhood Asthma,"In men with chronic obstructive pulmonary disease, use of short- and long-acting inhaled anticholinergic medications is associated with an increased risk for acute urinary retention."
May 2011 ,Medscape Medical News,Inhaled Anticholinergics Linked to Acute Urinary Retention,The product may be associated with an increased risk for necrotizing enterocolitis; healthcare professionals should stop administering the product to premature infants.
May 2011 ,Medscape Medical News,FDA Warns Against Use of SimplyThick in Premature Infants,"Results of this study have possible suggestions for long-term aspirin use in the prevention of chronic disease, as aspirin dose appears to be more important than aspirin duration."
August 2011 ,Heartwire from Medscape,UK's NICE Wants More Cost-Effectiveness Data on Dabigatran,NICE is requesting further cost-effectiveness analyses comparing dabigatran with warfarin using different effectiveness data and different scenarios for reflecting the cost of warfarin monitoring.
August 2011 ,Heartwire from Medscape,Deaths Prompt Dabigatran Safety Advisory in Japan,"According to Boehringer Ingelheim, treatment with Prazaxa, as it is known in Japan, could not be completely ruled out as a cause of death in five patients, one of whom had kidney failure (a contraindication) and four of whom were aged over 80."
August 2011 ,Medscape Medical News,Jury Still Out on Somatropin and Increased Risk for Death,The FDA advises clinicians to still prescribe recombinant human growth hormone even as the agency continues to weigh a French study that linked the therapy to a higher risk for death.
August 2011 ,Heartwire from Medscape,New Pioglitazone Label Highlights Bladder-Cancer Risk,The updated label states that pioglitazone should not be started in patients with active bladder cancer and should be used with caution in patients with a prior history of bladder cancer.
August 2011 ,Heartwire from Medscape,Caution Needed With Dabigatran (Pradaxa),"Caution must be exercised when prescribing the new anticoagulant dabigatran to prevent stroke in atrial-fibrillation patients who are elderly and frail, say doctors."
August 2011 ,Medscape Medical News,FDA Warns Against Fluconazole (Diflucan) in Early Pregnancy,The agency says long-term use of fluconazole (Diflucan) in high doses in the first trimester may be associated with birth defects.
July 2011 ,Medscape Medical News,FDA Warns Against Counterfeit Morning-After Pill,"An unapproved morning-after pill called Evital has not been shown to be safe or effective in preventing pregnancy, the FDA warns. "
July 2011 ,Medscape Medical News,FDA: Avoid Methylene Blue or Linezolid With Serotonergics,The FDA warns that coadministration of either methylene blue or linezolid and certain serotonergic agents can lead to an interaction triggering serotonin syndrome.
July 2011 ,Heartwire from Medscape,EMA Updates on Pioglitazone and Varenicline,"The European drug regulator is recommending a label change for one drug, and a stay-the-course message for the second."
July 2011 ,Medscape Medical News,"FDA Studying Link Between Bisphosphonates, Esophageal Cancer",The agency continues to review studies that reach different conclusions on the possible association between esophageal cancer and the widely prescribed drugs for osteoporosis.
July 2011 ,Medscape Medical News,Chemo Toxicity May Tip Scales in Advanced Hodgkin's Lymphoma,Overall survival nearly evened out in a clinical trial comparing 2 chemotherapy regimens; adverse events might be a deciding factor in choosing one or the other.
July 2011 ,Medscape Medical News,Etravirine Shows Fewer Neuropsychiatric AEs Than Efavirenz ,"Compared with efavirenz, etravirine appears to be associated with fewer neuropsychiatric adverse events."
July 2011 ,Medscape Medical News,Single Lot of Calcium Gluconate Injection Recalled,"American Regent is voluntarily recalling its calcium gluconate injection, USP, 10% 100 mL pharmacy bulk package, lot number 1006, because some vials may contain silicone particles."
July 2011 ,Medscape Medical News,Benefits of Ovarian Suppression During Breast Cancer Chemo,"The rate of early menopause is significantly reduced, but any fertility benefit is unknown."
July 2011 ,Medscape Medical News,New FDA Watch List Has Drug Making Fifth Straight Appearance,"Several of the potential signals in 2010 of serious risks for dronedarone, an antiarrhythmic, have been followed by label changes."
July 2011 ,Medscape Medical News,H1N1 Flu Vaccine Not Linked to Guillain-Barré Syndrome,"In a case-control study, the risk for Guillain-Barré syndrome was not increased after pandemic influenza vaccine, but the upper limit did not exclude a potential increase in risk up to 2.7-fold."
July 2011 ,Reuters Health Information,"Thyroid Effects of Generic, Brand-Name Amiodarone Similar","The anti-arrhythmic drug amiodarone is linked with similar rates of thyroid effects whether patients take the brand-name drug or a generic, Canadian research shows."
July 2011 ,Medscape Medical News,Lower Concentration for Oseltamivir Oral Suspension ,The influenza drug will become available in the new 6 mg/mL formulation this month. The old 12 mg/mL version will remain on the market until supplies run out.
July 2011 ,Medscape Medical News,FDA Reminds Clinicians About Risks With Belatacept,The manufacturer was required to inform clinicians and patients about the risk for posttransplant lymphoproliferative disorder and progressive multifocal leukoencephalopathy when the FDA okayed the kidney transplant drug.
July 2011 ,Medscape Medical News,Pediatric Collaborative May Reduce Adverse Drug Events,A pediatric collaborative addressing systems of medication delivery was associated with lower rates of adverse drug events at participating institutions.
September 2011 ,Heartwire from Medscape,Beware Bleeding With SSRIs and Antiplatelets,"Selective serotonin-reuptake inhibitor antidepressants appear to increase the risk of bleeding in patients taking antiplatelet agents, a new study suggests."
September 2011 ,Medscape Medical News,IMRT Reduces GI and GU Toxicity in Prostate Cancer,Men treated with the newer technology had fewer late bowel and rectal complications than those treated with 3D-conformal radiation therapy.
September 2011 ,Medscape Medical News,5-Year Data: Hypofractionated Radiation for Prostate Cancer,"The newer technology reduces treatment time by 2.5 weeks, but late bladder toxicity is a concern."
September 2011 ,Medscape Medical News,FDA Still 'Concerned' About Drospirenone VTE Risk,The US Food and Drug Administration remains concerned about drospirenone-containing oral contraceptives and increased risk for venous thromboembolism.
September 2011 ,Heartwire from Medscape,Europeans Looking Again at Orlistat and Liver Injury,"The European Medicines Agency says that it has started a review of orlistat-containing medicines to determine whether the ""very rare cases of hepatic injury have an impact on their benefit/risk profile and conditions of use."""
September 2011 ,Heartwire from Medscape,French Judges Charge Servier Head in Mediator Scandal,French magistrates allege that Jacques Servier engaged in dishonest practices and deception over the drug's quality and falsely obtained authorization to sell the controversial diabetes drug.
September 2011 ,Heartwire from Medscape,EMA Recommends Restricting Use of Dronedarone,"The EMA committee states that because of the increased risk of liver, lung, and cardiovascular adverse events, dronedarone ""should only be prescribed after alternative treatment options have been considered."""
September 2011 ,Medscape Medical News,Qualitest Oral Contraceptives Recalled,A packaging error has prompted generic drugmaker Qualitest Pharmaceuticals to recall multiple lots of oral contraceptives.
September 2011 ,Medscape Medical News,"Ondansetron Linked to Arrhythmias, FDA Warns",The FDA is revising the drug’s label to warn that patients with congenital long QT syndrome may run the risk for torsades de pointes.
September 2011 ,Medscape Medical News,Nonaspirin NSAID Use Linked to Risk for Renal Cell Cancer,Data from 2 prospective studies show an association between long-term use of nonaspirin anti-inflammatory drugs and the risk for renal cell cancer.
September 2011 ,Medscape Medical News,"Clarify Duration of Bisphosphonate Use, FDA Panel Says",An FDA panel has advised the FDA to be more specific about the duration of bisphosphonate use for the treatment of osteoporosis.
September 2011 ,Medscape Medical News,Adverse Drug Reactions Often Preventable,A meta-analysis shows that many adverse drug reactions that occur in the hospital and during emergency care are preventable.
September 2011 ,Medscape Medical News,Incidence of Thromboembolic Events With Cisplatin Too High,"The incidence of thromboembolic events in patients receiving cisplatin-based chemotherapy is unacceptably high, a retrospective analysis concludes."
September 2011 ,Reuters Health Information,HCV Therapy Can Cause Mild Depression to Spike,"Depressive symptoms may worsen during antiviral therapy among patients with hepatitis C virus, and notable changes in patients with subclinical depressive symptoms at baseline may be of most concern."
September 2011 ,Medscape Medical News,NSAIDs in Early Pregnancy Linked to Risk for Miscarriage, A case-control study shows a 2.4-fold increased risk for miscarriage in women who took any type and dosage of nonaspirin nonsteroidal anti inflammatory drugs in early pregnancy.
September 2011 ,Medscape Medical News,Atypical Antipsychotic Linked to Life-Threatening Reactions,"The FDA has issued a warning about the atypical antipsychotic Saphris, which has been linked to serious allergic reactions. "
August 2011 ,Medscape Medical News,"Few Adverse Events Linked to Vaccines, IOM Panel Says","The expert committee also reported that scientific evidence favors rejecting a causal relationship between autism and the measles, mumps, and rubella vaccine."
August 2011 ,Medscape Medical News,Macrolide Useful in COPD But May Cause Hearing Loss,A macrolide antibiotic given daily for 1 year in addition to usual treatment reduced chronic obstructive pulmonary disease exacerbations and improved quality of life but caused hearing decrements.
August 2011 ,Medscape Medical News,Biologics for Psoriasis May Not Raise Cardiovascular Risk,"Use of certain biologic therapies for psoriasis was not associated with a significant difference in rate of major adverse cardiovascular events vs placebo, but the study may have been underpowered."
August 2011 ,Medscape Medical News,High Doses of SSRI Linked to Abnormal Heart Rhythm,The SSRI citalopram should not be used in doses higher than 40 mg/day because of concerns that it may cause abnormal and potentially fatal changes in heart rhythm.
November 2011 ,Heartwire from Medscape,Dabigatran: 260 Fatal Bleeds Since Approval Worldwide,"Events occurred from March 2008 to October 31, 2011. European regulators are monitoring the issue and say that changes to the drug's current usage instructions 'adequately manage the risk of bleeding.'"
November 2011 ,News Alerts,Buflomedil-Containing Drugs May Be Suspended in EU,The European Medicines Agency is recommending suspension of all buflomedil-containing medicines.
November 2011 ,Heartwire from Medscape,Dronedarone a Hazard in High Risk Patients With Permanent AF,"The antiarrhythmic, approved for paroxysmal or intermittent AF, upped the risk of stroke, heart failure, and arrhythmic death in patients with permanent AF and other CV risk factors."
November 2011 ,Medscape Medical News,ASCO Updates Guidelines on Antiemetics,New recommendations for preventing vomiting and nausea caused by cancer treatments are published.
November 2011 ,Medscape Medical News,HIV Patients on HAART Have a Plethora of Ocular Diseases,"The prevalence of cataracts among HIV-positive patients receiving HAART is 10 times higher than in the rest of the American population, and the cataracts develop at a much younger age."
October 2011 ,Heartwire from Medscape,Renal-Assessment Update Issued for Dabigatran,Boehringer Ingelheim has agreed with the European Medicines Agencies to issue an update to the labeling for dabigatran.
October 2011 ,Medscape Medical News,FDA Provides Update on Drospirenone VTE Risk,"Further analysis of an FDA-funded study provides more evidence that drospirenone-containing oral contraceptives increase risk for venous thromboembolism, the agency says. "
October 2011 ,Medscape Medical News,Thyroid Testing Urged for Cancer Patients On Newer Therapies,"Newer targeted therapies and immunotherapies are associated with thyroid dysfunction, which can be mistaken for drug toxicity and lead to unnecessary dosage reductions."
October 2011 ,Medscape Medical News,Sepsis Drug Xigris Pulled From Worldwide Market,"Physicians should stop ongoing treatment with the drug now that it has failed a new efficacy test, according to the FDA."
October 2011 ,Medscape Medical News,MS Relapse Seen After Natalizumab Drug Holiday ,"The risks of natalizumab treatment interruption, even with an alternative immunomodulatory therapy, appear to outweigh the theoretical benefits, researchers say. "
October 2011 ,Medscape Medical News,"FDA Updates Warnings on Methylene Blue, Linezolid, and Serotonergics ","The agency now says that combining methylene blue or linezolid with SSRIs and SNRIs can trigger serotonin syndrome, but this risk may not apply to other serotonergic agents."
October 2011 ,Heartwire from Medscape,"EMA Reviewing Safety of NSAIDs, Clarifies on Pioglitazone","The EMA has launched a new review of the cardiovascular safety of NSAIDs, while also clarifying a previous opinion on the use of the antidiabetic agent pioglitazone and the risk of bladder of cancer."
October 2011 ,Heartwire from Medscape,EMA Review Concludes: No Cancer Risk With ARBs,"The European Medicines Agency ""concludes that benefit/risk balance of angiotensin-II-receptor antagonists remains positive,"" a press release from the agency states today."
October 2011 ,Medscape Medical News,Erectile Dysfunction Common With Colorectal Cancer Treatment,"A small survey found that most men developed erectile dysfunction after their colorectal cancer treatment, and that it caused ""profound distress."""
October 2011 ,Heartwire from Medscape,Dabigatran: Australia Issues Bleeding Warning,"The Australian regulatory authority has issued a ""safety advisory"" on the new oral anticoagulant dabigatran because of an increase in the number of bleeding-related adverse events reports received since it was approved for use in AF patients. "
October 2011 ,Medscape Medical News,Long-Term Pulmonary Toxicity From Breast Irradiation,There is good news from the first study -- a randomized trial -- reporting long-term toxicity outcomes after breast cancer therapy.
October 2011 ,Heartwire from Medscape,Fuel to the Fire or Flame Retardant? More on ARB Use/Cancer,"The use of angiotensin-receptor blockers or ACE inhibitors is not associated with a significantly increased risk of cancer, according to a new meta-analysis. The findings add yet another twist to the debate over whether or not the antihypertensive medications are associated with increased cancer incidence."
October 2011 ,Medscape Medical News,Reassuring Findings on Anticholinergics in Dementia Patients,New research suggests that medications with mild anticholinergic effects don't cause further cognitive decline in patients with Alzheimer's disease.
September 2011 ,Heartwire from Medscape,Clopidogrel Hypersensitivity Treated With Steroids a Success,"A new study has confirmed that virtually all patients with allergic reactions to clopidogrel respond favorably to a three-week course of prednisone, without having to interrupt antiplatelet therapy."
September 2011 ,Heartwire from Medscape,More Data Reignite Debate on ARB-Lung Cancer Risk ,"A new study, this time in kidney-transplant recipients, has found that those who took ACE inhibitors or angiotensin-receptor blockers had an increased risk of respiratory tumors if they also had a history of smoking. Some dismiss the findings, but others say they warrant further investigation."
January 2012 ,Heartwire from Medscape,Contaminated Cardiac Drugs Kill More Than 100 in Pakistan,More than 100 people have died in Pakistan and hundreds more have been hospitalized after having received contaminated cardiac drugs.
January 2012 ,Medscape Medical News,Most Adverse Events in Hospitals Go Unreported,"The main reason for incidents falling through the cracks is that staff does not perceive the event as reportable, says a new study from HHS. Nurses did most of the reporting that occurred."
January 2012 ,Medscape Medical News,Pharmacists' Role Critical to Patient Safety,Pharmacists play a key role in reducing adverse drug events and improving patient safety during care transitions.
December 2011 ,News Alerts,FDA Warns About Potential Mix-Ups With Durezol and Durasal,"Because the product names are similar, a pharmacist accidentally dispensed the wart remover instead of the prescription eye drops to a patient, leading to a serious injury."
December 2011 ,Heartwire from Medscape,"Adverse Events When Aliskiren Added to ACE, ARB Therapy","Data and safety monitors for ALTITUDE noted that patients in the trial taking aliskiren instead of placebo on top of ACE or ARB therapy experienced an increased incidence of nonfatal stroke, renal complications, hyperkalemia, and hypotension."
December 2011 ,News Alerts,FDA to Study Death of Patient After First Fingolimod Dose,The agency said it still believes the benefits of the drug to treat relapsing forms of multiple sclerosis outweigh potential risks. The cause of the patient's death remains to be determined.
December 2011 ,News Alerts,FDA Revises Dose for Simvastatin With Amiodarone,The agency is raising the allowed dose for simvastatin in combination with the cardiac drug back to 20 mg after mistakenly lowering it to 10 mg in June.
December 2011 ,News Alerts,Riata ICD Lead 'Alert' Is Now a Class I Recall,"The US FDA has designated a recent physician advisory letter relating to St Jude Medical's Riata family of ICD leads as a class I recall, the most serious. The letter, issued last month, warned doctors that more leads than it first thought were affected by a problem related to insulation failure."
December 2011 ,Medscape Medical News,American Dental Association Updates Osteonecrosis Guidelines,"Shifting away from an emphasis on intravenous bisphosphonates, the American Dental Association Council on Scientific Affairs points to a dose-response effect with antiresorptive therapy."
December 2011 ,Medscape Medical News,Baseline 'Bother' Predicts Quitting Aromatase Inhibitors,What is associated with postmenopausal women discontinuing aromatase inhibitors?
December 2011 ,Medscape Medical News,New Evidence Addresses ADHD Meds and Adult CVD Risk,"A large observational study provides reassuring news on the safety of medications for attention-deficit hyperactivity disorder in middle-aged adults, researchers say."
December 2011 ,News Alerts,FDA Investigating Serious Bleeding Events With Dabigatran,The agency wants to know whether bleeding events are occurring more commonly than would be expected based on data from the RE-LY trial.
December 2011 ,News Alerts,FDA Relaxes REMS Requirements on 2 Low Platelet Drugs,"The US FDA has dropped a requirement that prescribers and patients enroll in a monitoring network to use Nplate and Promacta, among other changes. "
December 2011 ,Medscape Medical News,Don't Use Vemurafenib in Earlier-Stage Melanomas,Could RAF inhibitors cause other cancers over time?
November 2011 ,Medscape Medical News,Tenofovir Associated With Nonreversible Kidney Disease,Tenofovir for treating HIV is associated with increased risk for kidney disease; this risk does not appear to be reversible after discontinuation.
November 2011 ,Medscape Medical News,4 Drugs Cause Most Adverse-Event Hospital Stays for Seniors,"Most emergency hospitalizations for seniors caused by adverse drug events involve a handful of anticoagulants and diabetes medications, according to a new study."
November 2011 ,Heartwire from Medscape,Merck Vioxx Payout in US Approaches $1 Billion,"Concluding a long-running investigation into promotion of its COX-2 inhibitor, rofecoxib, Merck has agreed to pay out almost $1 billion to the US federal government and most states. But the company still does not admit any wrongdoing with regard to the cardiovascular safety of the drug."
November 2011 ,Medscape Medical News,Joint Supplements for Aromatase Inhibitor Adverse Effects,"In combination, glucosamine and chondroitin appear to ease joint pain and improve function in breast cancer patients taking aromatase inhibitors. "
November 2011 ,Medscape Medical News,Adverse CNS Effects of HCV Treatment Discourage Adherence,"Medications for hepatitis C virus (HCV) can exacerbate cognitive deficits that are already seen in patients with chronic liver disease, and pose a risk to treatment adherence."
November 2011 ,Heartwire from Medscape,Transapical TAVI Stopped Due to Adverse Events: STACCATO,"A study comparing the transapical approach for transcatheter aortic-valve implantation against conventional aortic-valve replacement surgery was stopped early due to an increase in adverse events, including an increased risk of major stroke and severe paravalvular leakage, in elderly patients eligible for surgery."
March 2012 ,News Alerts,EMA Recommends New Warnings on Osteoporosis Drug ,"The CHMP has confirmed a positive benefit-risk balance for strontium ranelate, but recommends new contraindications and revised warnings. "
March 2012 ,Medscape Medical News,New Report: Cancer and CVD After Radiation Therapy ,Radiation therapy saves lives but might induce diseases that threaten once again to take them away.
March 2012 ,Medscape Medical News,"Steroids Linked to Suicide, Neuropsychiatric Disorders","Glucocorticoids, which are widely used to treat asthma, rheumatoid arthritis, and other autoimmune diseases, have been linked to a significant risk for suicide, mania, delirium, and depression."
March 2012 ,News Alerts,FDA: New Risks for Statins With HIV/HCV Protease Inhibitors,"Interactions between 4 statins and protease inhibitors can increase statin exposure and cause muscle injury, including a form that can lead to kidney failure."
March 2012 ,Medscape Medical News,New Option for Common Capecitabine Adverse Effect?,Hand-foot syndrome occurs in many colorectal cancer patients treated with this chemotherapy. Can an anti-inflammatory help?
February 2012 ,Reuters Health Information,Phosphate Enemas May Be Deadly in Elderly: Report,"Sodium phosphate enemas may cause older people to suffer kidney failure or even die, a new report suggests."
February 2012 ,Medscape Medical News,Some FDA Warnings Have Minimal Effect ,"A new study finds that many US Food and Drug Administration drug risk communications have a delayed effect, unintended consequences, or no effect."
February 2012 ,Heartwire from Medscape,Over 1300 Deaths in Mediator Scandal in France ,"The number of deaths attributable to heart-valve insufficiency as a result of the use of benfluorex in France is likely more than double that previously thought, a new investigation finds."
February 2012 ,Medscape Medical News,Chemotherapy During Pregnancy Appears Safe for Offspring ,"Children exposed to chemotherapy during the prenatal period appear to develop as well as those in the general population, without increased cardiac or neurologic morbidity. "
February 2012 ,News Alerts,"Boceprevir May Make Some HIV Drugs Less Effective, FDA Warns","The FDA warns clinicians and patients about ""important"" drug interactions between boceprevir and ritonavir-boosted anti-HIV protease inhibitors."
February 2012 ,Medscape Medical News,"Fatal Adverse Events with Pazopanib, Sorafenib, Sunitinib","These targeted therapies represent a major step forward in the treatment of cancer, but are associated with fatal adverse events. "
February 2012 ,Medscape Medical News,Bisphosphonates Raise Contralateral Atypical Fracture Risk,A study of atypical femur fractures shows an increase in contralateral fractures in patients continuing bisphosphonates.
February 2012 ,News Alerts,Proton Pump Inhibitors Linked to C difficile Diarrhea,"The FDA is warning that PPIs may be associated with a higher risk for Clostridium difficile-associated diarrhea, a persistent illness that comes with abdominal pain and fever."
February 2012 ,Medscape Medical News,FDA Panel Raises Concerns Over ADHD Drug Labeling,The FDA's Pediatric Advisory Committee has recommended labeling changes for an attention-deficit/hyperactivity disorder drug and discussed adverse effects.
February 2012 ,Medscape Medical News,FDA Says Tamsulosin Safe in Pediatric Patients,The panel concurred with the FDA that tamsulosin can return to routine safety monitoring.
February 2012 ,Medscape Medical News,"EBRT More Costly, Toxic Than Other Prostate Cancer Therapies",External-beam radiation therapy (EBRT) for prostate cancer is more costly and more toxic than either prostatectomy or brachytherapy.
January 2012 ,Medscape Medical News,FDA Panel Says Omalizumab Safe in Pediatric Patients,The Pediatric Advisory Committee Panel has recommended a return to routine monitoring in patients aged 6 to 11 years who are receiving omalizumab.
January 2012 ,Medscape Medical News,HPV Vaccine Policy: At Odds With Evidence-Based Medicine?,"According to a new study, there is a major discrepancy in claims regarding the safety and efficacy of the human papillomavirus (HPV) vaccines."
January 2012 ,Medscape Medical News,"Oxaliplatin Has Few Benefits, High Toxicity in Rectal Cancer",Long-term results from the French ACCORD 12 trial show that adding oxaliplatin to capecitabine plus radiotherapy does not improve survival in rectal cancer.
January 2012 ,Medscape Medical News,IMRT Slows Radiation-Related Osteoradionecrosis,"Osteoradionecrosis appears delayed with intensity-modulated radiation therapy (IMRT); however, some complications still occur."
May 2012 ,Medscape Medical News,Are Calcium Channel Blockers Radioprotective?,"Antihypertensive medications might block late radiotherapy toxicity, but there are still many questions."
May 2012 ,News Alerts,FDA Updates Safety Information for Lenalidomide,"In an update to their ongoing review, the FDA has added safety information to lenalidomide's labeling to inform patients and physicians of an increased risk for secondary cancers. "
May 2012 ,Medscape Medical News,New Antivirals Show Poor Safety in HCV With Cirrhosis ,"Two direct-acting antiviral drugs have poor safety profiles in compensated cirrhotic patients with hepatitis C virus (HCV), including many serious adverse events, but good efficacy."
April 2012 ,News Alerts,"Boceprevir Not Recommended With Certain HIV Drugs, FDA Says","Combining the hepatitis C drug with HIV drugs boosted by ritonavir for coinfected patients can lessen the effectiveness of the drugs, according to the agency."
April 2012 ,Reuters Health Information,"Race and Perioperative Pain, Opioid Adverse Events in Children","Children of different races have unequal burdens of perioperative pain and risks of opioid-related adverse effects, according to a report today in Pediatrics."
April 2012 ,Reuters Health Information,Telaprevir May Cause Severe Cutaneous Eruptions,"The antiviral agent telaprevir (Incivek) has been associated with severe cutaneous eruptions, including the DRESS syndrome (drug reaction with eosinophilia and systemic symptoms)."
April 2012 ,News Alerts,FDA Issues Warning on Fentanyl Patches,"The new warning reiterates appropriate use of the patches to prevent life-threatening accidental exposure to the drug, particularly in children."
April 2012 ,Medscape Medical News,Benefits and Risks of Trastuzumab in Breast Cancer,"A systematic review shows that trastuzumab significantly increases survival in women with HER2-positive breast cancer, but also puts them at risk for heart problems."
April 2012 ,Medscape Medical News,FDA Puts 16 Drugs on Watch List,"Homicidal thoughts are a potential issue for 1 of the 16 drugs added to the agency watch list, but a drug's appearance does not mean the FDA has concluded that it causes the adverse event in question."
April 2012 ,News Alerts,PML Reported in MS Patient on Fingolimod,Novartis today reported a case of PML in a multiple sclerosis patient taking fingolimod.
April 2012 ,News Alerts,FDA Announces Safety Label Changes to Finasteride ,Updated labels for finasteride (1 mg and 5 mg) will warn that some sexual adverse effects may linger after the drugs are discontinued.
April 2012 ,News Alerts,FDA Adds VTE Risk to Drospirenone Label ,Patients using oral bisphosphonates for the first time may be at increased risk of developing scleritis and uveitis.
April 2012 ,Medscape Medical News,Bisphosphonates May Increase Risk for Uveitis and Scleritis,"If the FDA follows the recommendations, drug companies will have to either conduct phase 2 to 3 trials or do meta-analyses that rule out excess cardiovascular risk for new obesity drugs that do not have a signal for cardiovascular risk. Advisors voted 17 to 6 in favor of a cardiovascular-safety benchmark that equals the one for diabetes drugs."
March 2012 ,Heartwire from Medscape,'Safe' Obesity Drugs Need to Prove Absence of CV Risk,"In day one of a two-day meeting, members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee heard from experts in obesity, diabetes, cardiology, and statistics. Later today, the panel will vote on whether obesity drugs with no cardiovascular risk signal still need to rule out excess cardiovascular risk."
March 2012 ,Heartwire from Medscape,FDA Committee Grapples With CV Risks in Obesity Drugs,Treatment-induced menopausal symptoms in breast cancer patients can be considerably ameliorated with cognitive behavioral therapy and physical exercise.
March 2012 ,Medscape Medical News,Treatment-Induced Menopause Helped by Nondrug Therapies,"Citalopram, a commonly used SSRI, should not be used in doses greater than 20 mg/day in adults over 60 due to an increased risk of QT prolongation."
March 2012 ,News Alerts,"Lower Citalopram Dose Needed in Older Patients, FDA Warns",A hallmark of the toxic effects seems to be cutaneous necrosis on the ears and the appearance of autoantibodies.
March 2012 ,Medscape Medical News,Levamisole-Laced Cocaine May Unmask Autoimmune Process,A study shows that using more dental sedatives increases the rate of complications in pediatric dental patients.
March 2012 ,Medscape Medical News,Added Complications With More Dental Sedatives for Children,Black patients are at greatest risk for ventilatory-assisted hospitalization.
July 2012 ,Medscape Medical News,Prostate Cancer AEs Persist 5 to 10 Years After Treatment,"Average sexual and urinary dysfunction is still 'very poor' up to 10 years after treatment, a study finds."
July 2012 ,News Alerts,Lot of Vecuronium Bromide Under Recall,The US Food and Drug Administration has announced a voluntary manufacturer recall of one lot of injectable vecuronium bromide.
July 2012 ,Medscape Medical News,Antipsychotics Linked to Gestational Diabetes,"Women who use antipsychotics during pregnancy may be at risk of developing gestational diabetes, and their babies may be at risk for increased head circumference."
June 2012 ,Medscape Medical News,Voluntary Drug Event Reporting Systems Woefully Lacking,Health systems need to move beyond methods for adverse drug event detection that rely primarily on voluntary reporting and should use several different methods to detect multiple types of events.
June 2012 ,News Alerts,FDA Issues Update on QT Prolongation Risk With Ondansetron ,"The 32-mg single intravenous dose of ondansetron should be avoided, as it may cause QT interval prolongation and could lead to a potentially fatal heart arrhythmia."
June 2012 ,Heartwire from Medscape,Olmesartan Linked to Rare Serious GI Side Effects,A report from the Mayo Clinic suggests some patients on the hypertension drug olmesartan are at risk for severe intestinal inflammation.
June 2012 ,Medscape Medical News,Vitamin B12 Deficiency With Metformin Linked to Neuropathy,"In patients with type 2 diabetes taking metformin, vitamin B12 deficiency is linked to increased peripheral neuropathy. "
June 2012 ,Heartwire from Medscape,Acceptable Thrombosis Risk With Hormonal Contraceptives,"In the largest-ever study to look at arterial thrombotic complications as a result of the use of hormonal contraception, Danish researchers find the risks are, for the most part, acceptable, given the benefits of these products."
June 2012 ,Medscape Medical News,Glucarpidase for Methotrexate Toxicity Oncologic Emergency,Cancer patients on high-dose methotrexate who develop renal impairment and acute toxicity can be rescued with a single dose of the new agent.
June 2012 ,Heartwire from Medscape,Statins Linked to Fatigue in Randomized Study,Moderate doses of both simvastatin and pravastatin were associated with tiredness and exertional fatigue in what is thought to be the first randomized study to look at such adverse effects with statins.
June 2012 ,Medscape Medical News,"Duloxetine Useful in Chemo Neuropathy, But Avoid ALC","The antidepressant alleviated chemotherapy-induced neuropathy in what is described at a practice-changing trial, but patients with breast cancer should avoid acetyl-L-carnitine (ALC) supplements."
June 2012 ,News Alerts,Contraceptives Recalled Because of Packaging Flaw,"The US Food and Drug Administration is notifying healthcare professionals of a voluntary recall of levonorgestrel and ethinyl estradiol tablets (Introvale, Sandoz) because of a packaging flaw."
May 2012 ,Heartwire from Medscape,EU Medicines Agency Launches Adverse Drug Event Web Site,"In a move aimed at improving transparency, suspected side effects with any medicine approved via the centralized EU approvals procedure can now be searched on a new website."
May 2012 ,Medscape Medical News,Oral Methylnaltrexone for Opioid-Induced Constipation,DDW 2012: Half the patients responded to daily dosing.
May 2012 ,Medscape Medical News,Genetic Markers Linked to Prostate Radiation Toxicity,Identifying susceptibility markers could guide therapy in the future.
May 2012 ,Medscape Medical News,Lack of Awareness of Late Drug Effects in Cancer Survivors ,Very few primary care physicians are aware of all the main long-term complications from 4 commonly used chemotherapies.
May 2012 ,Medscape Medical News,'One-Two Punch' for Advanced Melanoma Is Less Toxic,Skin toxicities are a concern with new treatments for metastatic melanoma.
May 2012 ,Medscape Medical News,Olanzapine Reduces Breakthrough Chemo-Induced Emesis,"In the first study of its kind, olanzapine was significantly more effective than metoclopramide in stopping breakthrough chemotherapy-induced nausea and vomiting."
May 2012 ,News Alerts,FDA to Review CV Risk With Azithromycin,"In an observational study, during a five-day course of azithromycin therapy, patients had a small, increased chance of dying from sudden cardiac death compared with patients taking amoxicillin. The risk of death was higher among patients with the most baseline cardiovascular risk factors."
September 2012 ,News Alerts,FDA Warns of Burns From Topical Pain Relievers,The US Food and Drug Administration warns of the potential for burns with over-the-counter topical joint and muscle pain relievers.
September 2012 ,Medscape Medical News,Documented CNS Infections Accompanied Natalizumab Use,At least 17 patients taking natalizumab have experienced serious herpes simplex or varicella zoster infections since November 2004.
September 2012 ,Medscape Medical News,Public Citizen Sues FDA Over Safety of High-Dose Donepezil,A consumer watchdog group charges the FDA with not acting on its May 2011 petition to pull the 23-mg dose of donepezil from the market because of safety concerns.
September 2012 ,Medscape Medical News,Aloe Vera Reduces Severity of Dermatitis After Radiotherapy,"The prophylactic use of topical aloe vera, an ancient herbal remedy, significantly reduces the severity of radiation-induced dermatitis."
August 2012 ,Medscape Medical News,Risk for Heart Failure With Trastuzumab Higher Than Believed,Clinical trials have shown that anthracyclines and trastuzumab together increased the risk for heart failure; that risk appears to be even higher in a real-world setting.
August 2012 ,Medscape Medical News,Olanzapine Activates Food Reward Area of the Brain,"A new imaging study shows that olanzapine can trigger anticipatory responses to food in specific areas of the brain after just 1 week of treatment, contributing to significant weight gain."
August 2012 ,Reuters Health Information,Antiepilepsy Drug Rufinamide Tied to Weight Loss,"Nearly half of the patients taking rufinamide for epilepsy in a new case series developed clinically significant weight loss, according to French researchers."
August 2012 ,Medscape Medical News,New Anticancer Drugs Associated With Increased Toxicity,"Many of the new anticancer agents improve effectiveness, but they also increase morbidity and mortality because of their toxicity."
August 2012 ,Medscape Medical News,Diabetes: Another Late Complication of Radiotherapy ,"Among other late effects, cancer survivors who underwent abdominal or total body radiotherapy have an increased risk for diabetes."
August 2012 ,Medscape Medical News,Statin Potency Linked With Muscle Weakness ,The highest rates of muscle-related adverse effects are associated with the strongest statin drugs.
August 2012 ,Reuters Health Information,Fluoroquinolones Tied to Higher Risk of Serious Arrhythmias,"Fluoroquinolones, especially gatifloxacin, moxifloxacin and ciprofloxacin, are associated with significantly increased risks of serious arrhythmias, according to a new study."
August 2012 ,News Alerts,FDA Warns of Codeine Overdose Risk After Pediatric Surgery,A small percentage of children convert appropriate doses of codeine into potentially lethal levels of morphine in their bloodstream.
August 2012 ,Heartwire from Medscape,Statins Linked With Development of Cataracts,"Statin users are more than 50% likelier to develop age-related cataracts than nonusers, according to the results of a new study. And those with type 2 diabetes taking statins were at even greater risk, say the researchers. "
August 2012 ,Medscape Medical News,Photosensitizing Antihypertensives Raise Lip Cancer Risk,"Patients initiating hydrochlorothiazide or another photosensitizing agent need a reminder to avoid sun exposure, researchers say. "
July 2012 ,Medscape Medical News,Sirolimus Cuts Skin Cancer Risk in Transplant Patients,A switch to sirolimus appears to reduce the risk for new skin cancers in kidney transplant patients.
July 2012 ,News Alerts,"Calcitonin Linked to Cancer Risk, EMA Warns","The European version of the FDA is recommending market withdrawal of calcitonin nasal spray, used to treat osteoporosis. Two brand-name versions are marketed in the United States."
July 2012 ,Medscape Medical News,"FDA Puts 4 Drugs, X-Ray Contrast Agent on Watch List",An appearance on the list does not mean that the FDA has determined that the drug actually poses the reported health risk.
July 2012 ,News Alerts,Leucovorin Calcium Lots Subject to Voluntary Recall,Three lots of leucovorin calcium lots subject to recall due to evidence of particulate matter.
July 2012 ,Medscape Medical News,Platinum-Induced Ototoxicity in Children a Continuing Issue,"New recommendations have been made related to otoprotection in children receiving platinum-based chemotherapy, including a new ototoxicity scale."
July 2012 ,Medscape Medical News,Avoiding Severe Toxicity From 5-FU and Related Drugs,A multiparametric approach to screening identifies more patients who are likely to suffer toxic effects and who might even die from 5-fluorouracil (5-FU) and related chemotherapies.
December 2012 ,News Alerts,32-Mg IV Zofran Pulled From Market,"This particular dose of the antinausea drug can lead to a deadly heart rhythm, says the FDA, which expects voluntary recalls of generic versions as well."
November 2012 ,Medscape Medical News,Greater Monitoring of Clozapine for Serious AEs Needed,"Current guidelines require monitoring for agranulocytosis when using clozapine to treat schizophrenia, but new data strongly suggest additional monitoring for other adverse events is warranted."
November 2012 ,WebMD Health News,Drugs That Interact With Grapefruit on the Rise,"The number of drugs that can be risky when taken with grapefruit is on the rise, largely due to the influx of new medications and chemical formulations, a new study shows."
November 2012 ,Heartwire from Medscape,New WHI Analysis Links HRT to Atrial Fibrillation,Recent linkage of the WHI trials to the Medicare database has allowed researchers to accurately analyze the rate of AF among women taking HRT in the trial and compare it with those who were not taking hormones.
November 2012 ,Medscape Medical News,History of Atopy May Predict Serious Adverse Drug Reactions,"People with a history of asthma, eczema, allergic rhinitis, or an adverse reaction to drugs are more likely to have a severe adverse drug reaction to a new medication."
November 2012 ,Medscape Medical News,Excessive Acetaminophen Dosing Too Common in Hospitals,"Excessive amounts of acetaminophen were given to at least 4% of adult inpatients studied, according to a retrospective review of the electronic medical records of 14,000 patients."
November 2012 ,WebMD Health News,Spine Infections Hit Fungal Meningitis Survivors,A dangerous second infection seen in survivors of tainted-shot outbreak.
November 2012 ,News Alerts,FDA: Bleeding Risk With Dabigatran Similar to Warfarin,The US Food and Drug Administration has reported that the bleeding risk with dabigatran etexilate is comparable with that observed with warfarin.
November 2012 ,News Alerts,2nd Pharmacy Recalls Thousands of Drugs,"Ameridose, a Massachusetts compounding pharmacy closely linked to the NECC pharmacy at the heart of the fungal meningitis outbreak, today recalled thousands of drugs sold to hospitals across the U.S."
October 2012 ,Reuters Health Information,U.S. Regulator Needs New Authority Over Compounding Pharmacies: Report,"The U.S. Food and Drug Administration's power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday."
October 2012 ,News Alerts,"Child Poisonings From Eye Drops, Nose Sprays","Over-the-counter eyedrops and nose sprays contain powerful drugs that are poisonous in surprisingly small amounts if swallowed, the FDA warns."
October 2012 ,Medscape Medical News,Bisphosphonates and Esophageal Cancer: No Link Seen,A meta-analysis reveals no link between bisphosphonate use and esophageal cancer.
October 2012 ,Medscape Medical News,Drospirenone Increases Venous and Arterial Blockage Risks ,A large retrospective study found that women using oral contraceptives containing drospirenone were at significantly increased risk for arterial thrombotic and venous thromboembolic events.
October 2012 ,Medscape Medical News,FDA Adds 8 Drugs to Watch List,Making the list does not mean that the FDA has concluded that the drug poses the reported health risk.
October 2012 ,Medscape Medical News,Staph Vaccine Linked to Multiorgan Failure and Death,"A trial of an experimental vaccine against Staphylococcus aureus to prevent bacteremia and wound infections after surgery has produced disappointing results, despite a robust immunologic response."
October 2012 ,Medscape Medical News,Cognitive Training Helps 'Chemo Brain' in Cancer Survivors,Long-term breast cancer survivors stayed sharper with a computerized intervention designed to improve speed of processing.
September 2012 ,Medscape Medical News,High Incidence of Kidney Stones With Atazanavir ,"Patients taking ritonavir-boosted atazanavir were 10 times more likely to develop kidney stones than patients taking other protease inhibitors, a new study shows."
September 2012 ,Medscape Medical News,Study Stirs Controversy About Risks From Chemotherapy,"After 3 years of follow-up, there was no increased risk for blood cancers overall, but a prominent American oncologist has criticisms of the study."
September 2012 ,News Alerts,FDA Warns of Potential Heart Failure Risk With Pramipexole,FDA has notified healthcare professional of their ongoing review of pramipexole for potential heart failure risk.
September 2012 ,Medscape Medical News,Statins May Increase Pneumonia Risk ,"Statins might increase the risk for pneumonia, a new study suggests."
March 2013 ,Medscape Medical News,Web Searches May Help Identify Unreported Drug Adverse Effects,"Analyzing search terms people type into their Web browsers may help spotlight previously unknown harmful drug adverse effects, according to a study that examined the search habits of 6 million users."
March 2013 ,Medscape Medical News,Pruritus Risk High in Cancer Patients on Targeted Therapy,"Almost 20% of cancer patients receiving an epidermal growth-factor inhibitor or a mammalian target of rapamycin experience dermatologic adverse effects, 2 new studies show."
February 2013 ,Medscape Medical News,Ocular Complications After HSCT in Children,"In children, eye complications commonly develop within 1 year of hematopoietic stem cell transplantation (HSCT), but they generally do not threaten vision."
February 2013 ,Medscape Medical News,Risk for Acute Myeloid Leukemia Linked to Chemotherapy,The risk of developing treatment-related acute myeloid leukemia needs to be weighed against the benefits of chemotherapy
February 2013 ,News Alerts,Codeine in Young Children Linked to Serious Adverse Events ,The FDA is warning again that several young children have developed serious adverse events after receiving codeine for pain relief after tonsillectomy.
February 2013 ,Medscape Medical News,Mortality Doubles With High Calcium Intake Plus Supplements,"However, a new study results suggest that supplements, rather than intake level, are the problem."
February 2013 ,Medscape Medical News,Three Drugs Added to FDA Watch List,A drug's appearance on the list does not mean that the agency has concluded that the drug actually poses a health risk. The jury is still out.
February 2013 ,Reuters Health Information,Cardiovascular Toxicity With Tx for Advanced Kidney Cancer,"Agents that target the mTOR axis, which have become particularly important in treating advanced renal cell carcinoma (RCC), have significant adverse cardiovascular effects."
January 2013 ,News Alerts,France to Suspend Sale of Diane 35,"The French equivalent of the FDA said the acne drug, also used off-label as an oral contraceptive, raises the risk for deadly venous thromboembolism."
January 2013 ,News Alerts,"Tolvaptan Poses Risk for Serious Liver Damage, FDA Warns","The drug, approved for hyponatremia, probably caused the liver damage experienced by 3 patients during kidney disease trials, according to the agency."
January 2013 ,Reuters Health Information,Acute Anterior Uveitis After Intravenous Zoledronate,"About one in 100 patients could develop acute anterior uveitis (AAU) in the week after receiving intravenous zoledronate, researchers from New Zealand report."
January 2013 ,Medscape Medical News,Diphtheria Vaccine Administered in the Thigh Appears Safer ,A new study of 1.4 million children shows less risk for local reaction among those given the diphtheria vaccine in the thigh rather than the arm.
January 2013 ,News Alerts,Serious Skin Reactions Prompt EMA Review of Benzodiazepine,Concerns over serious skin reactions with medications containing a commonly used benzodiazepine have prompted a European Medicines Agency review.
January 2013 ,News Alerts,FDA Recommends Lower Bedtime Dose for Zolpidem,"On the basis of new data showing morning blood levels sufficiently high to impair alertness in some patients with insomnia, the agency is recommending lower bedtime doses of zolpidem products."
December 2012 ,News Alerts,FDA Warns Against Unapproved Drugs From Foreign Suppliers,The FDA has sent a letter to 350 medical practices in the United States over possible receipt of unapproved and possible unsafe medications from a foreign supplier.
December 2012 ,News Alerts,Telaprevir Linked to Potentially Fatal Skin Reaction,Some patients have died when they continued to receive telaprevir combination treatment after the onset of a serious skin reaction.
December 2012 ,Medscape Medical News,Safety Info for Generic Drugs Often Differs From Brand Label,Bioequivalent drugs often differ from brand name drugs in their safety labeling.
December 2012 ,Medscape Medical News,Genotype Predicts Treatment-Related Mortality in AML,The presence of a specific genetic marker appears to be correlated with less treatment-related mortality in certain populations.
December 2012 ,Medscape Medical News,"'Chemo Brain' May Actually Be Worry and Fatigue, Says Study",Cognitive problems can precede chemotherapy
December 2012 ,Medscape Medical News,FDA Rejects NRDC Petition to Ban Lindane ,The lice and scabies treatment is no longer widely used.
April 2013 ,Medscape Medical News,'One Size Fits All' Drug Dosing Gives Suboptimal Results,Many patients receive inappropriate drug doses and subsequently have poor results because drug serum levels are never tested.
April 2013 ,News Alerts,FDA Issues Warning About Antiseizure Drug Potiga,The US Food and Drug Administration has issued a warning that the antiseizure drug Potiga can cause pigment changes and eye abnormalities.
April 2013 ,Reuters Health Information,Steroids Tied to Local Reactions to Yellow Fever 17D Vaccine,"Patients receiving systemic corticosteroids seem to be at particular risk for local reactions to the yellow fever 17D vaccine, French researchers say."
April 2013 ,News Alerts,Another Compounding Company Recalls All Sterile Product,"Balanced Solutions Compounding Pharmacy has voluntarily recalled all lots of its sterile drug products because of sterility concerns, the FDA says. "
April 2013 ,News Alerts,FDA Announces Recall of ApotheCure and NuVision Products,US health regulators say sterile drug products from ApotheCure and lyophilized products from NuVision Pharmacy should not be administered to patients.
April 2013 ,News Alerts,Strontium Ranelate Restrictions Recommended in EU,An EU regulatory committee has recommended restricting the use of the osteoporosis drug strontium ranelate (Protelos/Osseor) to reduce the risk for adverse cardiac events in postmenopausal women.
April 2013 ,News Alerts,Drugs From Shamrock Medical Solutions May Be Mislabeled ,"All drugs distributed by Shamrock including tablets, vials, ophthalmic and otic solutions and patches should be removed from inventory and not used, the FDA said today. "
April 2013 ,News Alerts,Green Valley Drugs Announces Nationwide Recall,"Lack of ""sterility assurance"" prompts the company to recall all lots of all sterile products compounded, repackaged, and distributed by the pharmacy."
April 2013 ,Medscape Medical News,Preventing Heart Damage From Chemotherapy: OVERCOME Trial,A pilot study shows that the combination of enalapril plus carvedilol prevented left ventricular damage in cancer patients undergoing intensive chemotherapy.
April 2013 ,Medscape Medical News,Adverse Drug Events Found by Mining Clinical Notes in EHR ,Unstructured clinical notes written in electronic health records can be used to identify drug adverse events and drug-drug interactions.
April 2013 ,Medscape Medical News,Amiodarone Linked to Increased Cancer Risk in Men,The widely used antiarrhythmic drug appears to increase the risk for cancer in men in a dose-dependent manner.
April 2013 ,Reuters Health Information,Safety Warnings for High-Risk Meds Missing From Smartphone Apps,Most electronic pharmacopoeia (EP) smartphone apps do not place important safety warnings for extended release or long acting (ER/LA) opioid formulations ahead of or on the same screen as prescribing information.
April 2013 ,Medscape Medical News,'Call to Action' to Minimize Cataract Surgery Complications,"Surgical strategies and newer technology can protect children from major complications of cataract surgery, which can arise shortly after repair or decades later, so long-term monitoring is warranted."
April 2013 ,Medscape Medical News,Mirabegron Showing Promise for Overactive Bladder,"The safety and adverse-effect profile of mirabegron compares favorably with that of tolterodine and placebo, new research shows."
April 2013 ,Medscape Medical News,S aureus Vaccine for Heart Surgery Appears Harmful,A vaccine to prevent postoperative S aureus infection is associated with an overall lack of efficacy and a higher mortality rate in a randomized controlled trial.
April 2013 ,Medscape Medical News,Drug for Depression Mutes Chemo Nerve Pain,A phase 3 study demonstrates that duloxetine can improve chemotherapy-induced peripheral neuropathy.
March 2013 ,Medscape Medical News,Once-Daily Ribavirin Promising for Hepatitis C,"Once-daily ribavirin as part of triple therapy does not increase toxicity, and patients prefer it, a new study finds."
March 2013 ,News Alerts,EMA Recommends Restricting Cilostazol Use for PAD,The Europeans Medicines Agency has recommended restricting the use of cilostazol in patients with intermittent claudication. Use should be avoided in those with cardiac problems or on dual anticoagulants
March 2013 ,News Alerts,More Adverse Events Reported for Surgical Waste System ,"The recalled Stryker devices, still in use by facilities lacking an alternative, can damage soft tissue, muscle, and vital organs when improperly used. The FDA has received reports of injuries and deaths. "
March 2013 ,News Alerts,"Azithromycin Poses Fatal Cardiac Risk, FDA Warns",Clinicians should consider the risk for a prolonged QT interval and torsades de pointes in patients already at risk for adverse cardiovascular events.
June 2013 ,News Alerts,FDA Warns of Increased Mortality Risk With HES Solution,"Do not use hydroxyethyl starch solution in critically ill patients because of the increased risk for death and renal injury, the agency said today."
June 2013 ,Medscape Medical News,Entecavir May Prevent HBV Reactivation in Lymphoma Patients,Antiviral prophylaxis with entecavir might help prevent rituximab-associated hepatitis B virus (HBV) reactivation in patients with lymphoma and 'resolved' hepatitis B.
June 2013 ,Medscape Medical News,AMA Urges Insurers to Cover Fertility Preservation,The AMA has ruled that fertility preservation for patients diagnosed with cancer should be covered by insurance -- just as reconstruction after mastectomy is.
June 2013 ,Medscape Medical News,Drug Discontinuations Rampant in Rheumatoid Arthritis,"In the modern era of biologics, up to one third of patients with rheumatoid arthritis still discontinue therapy within a year, most often because of lack of efficacy."
June 2013 ,News Alerts,European Committee Recommends Restricting Flupirtine,"Reports of liver problems, including sometimes fatal liver failure, prompt drug risk committee to recommend restricting use to those unable to take other analgesics and weekly liver function tests."
June 2013 ,Medscape Medical News,Childhood Cancer Survivors May Have 'Premature Aging',"A new study reveals that by middle age, they have a high rate of health problems."
June 2013 ,Reuters Health Information,Dual HER-2 Blockade Doesn't Boost Cardiac Toxicity,Dual HER2 blockade didn't increase heart problems in a meta-analysis of data from patients with HER2-positive breast cancer.
May 2013 ,News Alerts,Almitrine Will Be Withdrawn as COPD Therapy in 3 EU Nations ,"Once a go-to treatment for chronic respiratory failure in France, Portugal, and Poland, almitrine no longer passes the benefit/risk test, say European drug regulators."
May 2013 ,News Alerts,EMA Recommends That Trobalt Be Last Line in Partial Epilepsy,"The Committee for Medicinal Products for Human Use recommends restricting use of retigabine, aka ezogabine, in the United States, to last-line therapy because of the risk for retinal pigmentation."
May 2013 ,Medscape Medical News,ASCO Issues Updated Guidelines on Fertility Preservation,The updated guidelines for fertility preservation in cancer patients reflect advances in the field and contain minor but important changes.
May 2013 ,Medscape Medical News,Repeated EHR Alerts Desensitize Clinicians,"Repeated inappropriate alerts in electronic health records desensitize clinicians and may cause them to overlook true positive alerts, as shown in a newly published case report."
May 2013 ,News Alerts,FDA Expands Alert to All Sterile NuVision Drug Products,The agency has recommended that health providers not use any sterile drug product made by Dallas-based compounding pharmacy NuVision because of concerns that the products may not be sterile.
May 2013 ,Medscape Medical News,Seniors at High Risk for Adverse Drug Events,"Therapeutic competition and adverse drug events jeopardize the health of older adults, 2 new studies show."
May 2013 ,News Alerts,EU Regulators Recommend Withdrawing Almitrine,"The benefits of almitrine in managing COPD no longer outweigh the risks of marked weight gain and peripheral neuropathy, given alternative treatments, a committee of the European Medicines Agency said. "
May 2013 ,News Alerts,FDA Label Changes for Zolpidem Products,A new safety communication from FDA recommends against next-day driving with extended-release zolpidem and approves dosing changes previously stated because of known next-morning risks.
May 2013 ,Medscape Medical News,Tearing Related to Docetaxel-Based Chemotherapy,"Tearing occurs in the majority of patients who receive adjuvant docetaxel-based chemotherapy regimens, but it is not caused by lacrimal duct obstruction."
May 2013 ,News Alerts,FDA Warns Against Valproate to Prevent Migraine in Pregnancy,The FDA strengthened warnings against use of valproate products to prevent migraine in pregnant women.
May 2013 ,News Alerts,"Latest FDA Watch List: 2 Drugs, All Acetaminophen Products",The FDA added acetaminophen products to the list after getting reports of severe skin reactions. The agency studies drugs on the list to determine if they actually cause the adverse events reported.
May 2013 ,Medscape Medical News,Zolpidem Linked to Sharp Increase in ED Visits,SAMHSA reports that drug-related emergency department visits for adverse events connected to the sleep medication zolpidem jumped by almost 220% from 2005 to 2010.
April 2013 ,News Alerts,FDA Limits Use of Samsca Due to Liver Injury Risk ,"The US Food and Drug Administration has announced new restrictions on the use of tolvaptan because of the potential risk for liver injury, including length of use."
September 2013 ,News Alerts,PRAC Recommends Restrictions on SABAs in Obstetrics,"The committee says short-acting beta-agonists should no longer be used in oral or suppository forms in obstetric indications, citing cardiovascular risks."
September 2013 ,Reuters Health Information,Pyridoxine Does Not Seem to Benefit Hand-Foot Syndrome,"Pyridoxine (vitamin B6) does not seem to benefit patients with hand-foot syndrome (HFS) caused by chemotherapy, a new meta-analysis suggests."
August 2013 ,Medscape Medical News,Genetic Marker May Identify Risk for Statin-Induced Myopathy ,Genetically determined variation in expression of the glycine amidinotransferase gene may be associated with differences in susceptibility to statin-induced myopathy.
August 2013 ,Medscape Medical News,Hodgkin's Lymphoma Treatment and Risk for Stomach Cancer,"The treatment for Hodgkin's lymphoma appears to increase the risk for stomach cancer, especially in patients who received high doses of abdominal radiation."
August 2013 ,Reuters Health Information,Skin Biopsies Not Useful for Diagnosing Drug-Induced Rash,"Skin biopsies are not useful in the differential diagnosis of drug-induced exanthems (DIE), a new retrospective study shows."
August 2013 ,Reuters Health Information,VEGFR-TKI Related Hemorrhages Usually Mild in Cancer Patients,"In cancer patients, use of vascular endothelial growth factor receptor-tyrosine-kinase inhibitors (VEGFR-TKIs) is linked to more hemorrhagic events, but these generally aren't high grade."
August 2013 ,News Alerts,FDA: Don't Use Any Sterile Product From NuVision Pharmacy,"Sterile products from NuVision may still pose serious risks to patients and should not be used, the FDA said. "
August 2013 ,Heartwire from Medscape,Genotyping Might Cut Muscle-Pain Risk With Statins,"Mutations that affect serum levels of two statins likely account for huge serum-level variations among patients, suggesting they could help guide statin dosing to avoid the drugs' major side effects; researchers say it's probably a statin class effect."
August 2013 ,News Alerts,More Injectable Benztropine Mesylate Recalled in US,"Nexus Pharmaceuticals has recalled more than 46,000 vials of benztropine mesylate because of the potential presence of particulate matter. "
July 2013 ,Reuters Health Information,Strong Genetic Link to Carbamazepine Skin Reactions in Asians,"A new review shows a 'strong' link between the HLA-B*1502 allele and carbamazepine-induced Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in Han-Chinese, Thai and Malaysian populations."
July 2013 ,Medscape Medical News,Birth Defects Linked to Mothers' Use of Cold Medicine,"However, the absolute number of cases was low, making true relationships hard to confirm and absolute risks small even with decongestant use, the authors warn."
July 2013 ,Medscape Medical News,EU Agency Has No New Concerns on Incretin Diabetes Drugs ,"Current data do not confirm recent concerns over an increased risk for pancreatic adverse events with GLP-1-based type 2 diabetes drugs, says the European Medicines Agency."
July 2013 ,News Alerts,Europe Recommends Restrictions for Metoclopramide,The Committee on Medicinal Products for Human Use has recommended restrictions on metoclopramide to minimize neurologic adverse effects.
July 2013 ,Medscape Medical News,New Results for ESAs in Early Breast Cancer Reignite Debate,Results from a study of the use of an erythropoiesis-stimulating agent (ESA) to treat chemotherapy-induced anemia in patients with early-stage breast cancer have now been published.
July 2013 ,Reuters Health Information,Merck Says FDA Needs More Time for Post-Surgery Drug Review,"Merck & Co Inc said on Tuesday that U.S. health regulators need more time to review its application to sell sugammadex, an injection designed to reverse the effects of muscle relaxants used during surgery. "
July 2013 ,Heartwire from Medscape,"Beta-blockers in HF Get Bum Rap for Most 'Side Effects,' Says Study","Many adverse effects linked to beta-blockers in heart-failure trials, which made their way into the labeling, were shown in a new analysis to have been no more common with the drugs than with placebo. The result is a disaster for some patients, according to researchers."
July 2013 ,Medscape Medical News,Acute Renal Injury May Be Associated With mTOR Inhibitors,French researchers have observed a potentially new and serious adverse consequence in cancer patients treated with an mTOR inhibitor.
June 2013 ,Medscape Medical News,"Vaccines Not Linked to Guillain-Barre, Asserts 13-Year Trial","A large retrospective analysis spanning 13 years found no association between vaccinations and development of Guillain-Barre syndrome; but not everyone agrees, and a few gnawing questions remain."
June 2013 ,Medscape Medical News,Largest Steroid Injection Outbreak Kills 55 People,CDC researchers have established that immunohistochemistry analysis is highly sensitive in detecting fungus.
June 2013 ,News Alerts,"FDA Adds Antinausea, Cardiac Drugs to Watch List",A drug's appearance on the FDA watch list does not mean the agency has determined that there is a causal link to reported health problems.
November 2013 ,News Alerts,EU Strengthens Warning on Ponatinib,"Ponatinib will remain on the European market for now, but will have a stronger warning about the associated risk for cardiovascular toxicity."
November 2013 ,Medscape Medical News,"Market Removal of Ponatinib Raises Questions, Concerns","The sales and marketing suspension of ponatinib raises questions about accelerated drug approvals, the monitoring of cardiovascular toxicity in cancer patients, and the evaluation of risks and benefits."
November 2013 ,Medscape Medical News,Bariatric Surgery Safe in Severely Obese Teenagers ,"The Teen-LABS study provides some important early safety data and insights into the comorbidities of teenagers, who undergo bariatric surgery. "
October 2013 ,News Alerts,FDA Label Changes Underline Risks With Ezogabine,"FDA has announced approval of label changes for ezogabine (Potiga) to underline risks for retinal abnormalities, potential vision loss, and skin discoloration, including a new boxed warning."
October 2013 ,Medscape Medical News,Sorafenib Side Effects Not Inconsequential in Thyroid Cancer,"The drug's side effects, particularly hand-foot skin reactions, stand out in a health-related quality of life assessment of the DECISION trial."
October 2013 ,Medscape Medical News,"Physicians Mum About Overdiagnosis Risks, Patients Say","Clinicians may not tell most patients about the possibility of overdiagnosis and overtreatment as a result of cancer screenings, according to a patient survey. "
October 2013 ,Medscape Medical News,Bariatric Surgery: BMI Disputed as Key Eligibility Criterion ,"Age and diabetes, not BMI, turn out to be major predictive factors for mortality in obese individuals and should be used as criteria for bariatric surgery eligibility."
October 2013 ,Medscape Medical News,Chemo-Induced Menopause Symptoms Similar to Spontaneous,"Whether menopause is treatment-induced or spontaneous, the symptoms are alike, a new study has found."
October 2013 ,Reuters Health Information,Nursing Intervention Improves Pelvic Radiation Bowel Symptoms,"Patients with radiotherapy-induced gastrointestinal symptoms who receive a targeted intervention do better than those given usual care, UK researchers say."
October 2013 ,Reuters Health Information,Heart Failure With Trastuzumab in Women With Cardiac Comorbidity,"Breast cancer patients treated with trastuzumab are at high risk of congestive heart failure(CHF), particularly if they are older or have cardiac comorbidities, a new study shows."
October 2013 ,Medscape Medical News,"Metoclopramide: No Link Seen With Birth Defects, Stillbirth ","A study of more than 40,000 women who used metoclopramide during pregnancy found no significant link between use of the drug and risks for congenital malformations or other adverse outcomes. "
October 2013 ,Medscape Medical News,Debate Continues on Osteoporosis Treatment in CKD ,Whether to treat patients with chronic kidney disease with osteoporosis drugs to reduce fracture risk was the subject of a heated debate at the ASBMR meeting last week.
October 2013 ,Medscape Medical News,Pancreatic Atrophy: Adverse Effect of Long-term Sorafenib?,Two patients who had been taking sorafenib for 2.5 to 3 years were found on CT scans to have a 20% to 25% decrease in pancreas volume.
September 2013 ,News Alerts,Tigecycline Mortality Risk: FDA Adds Boxed Warning,The FDA advises clinicians to use the intravenous antibiotic only 'in situations where alternative treatments are not suitable.'
September 2013 ,Medscape Medical News,Vancomycin Alternatives Don't Improve Kidney Outcomes,"Switching high-risk patients to an alternative to vancomycin does not change the nephrotoxicity, researchers warn."
September 2013 ,Medscape Medical News,Microbiota Predict Chemotherapy-Induced Diarrhea,"For the first time, researchers have linked changes in gut microbiota and chemotherapy-induced diarrhea in patients with non-Hodgkin's lymphoma."
September 2013 ,News Alerts,FDA Restricts Long-term Opioid Use to Combat Abuse,"The indication is no longer for 'moderate to severe pain,' but 'pain severe enough' to warrant 24/7 medication when other treatments fail."
September 2013 ,Medscape Medical News,"Day-of-Week, Hospital Volume Differences in Delivery Outcome",Day of week and hospital volume affect asphyxia at birth and cesarean rates.
September 2013 ,News Alerts,Serious Skin Reactions Reported With Sunitinib (Sutent),"Toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported ""very rarely"" in patients taking sunitinib (Sutent). Two cases were fatal. "
September 2013 ,News Alerts,PRAC Wants Numeta G13%E Off the Market,The committee wants marketing authorization of the intravenous nutrition preparation Numeta G13%E suspended because of a risk for hypermagnesemia in premature infants.
January 2014 ,Medscape Medical News,Researchers Uncover Mechanisms of ICU Delirium,New discoveries about delirium and coma in patients in the intensive care unit (ICU) could lead to new treatments.
January 2014 ,Medscape Medical News,5-Fluorouracil Effective Treatment for CIN 2 in Small Trial,Topical 5% 5-fluorouracil may be an effective treatment for cervical intraepithelial neoplasia 2 in women.
January 2014 ,FDA Approvals,FDA Approves First Combination Therapy for Melanoma,Both drugs were previously approved for single-agent use in advanced melanoma.
January 2014 ,News Alerts,Nipro Glucose Meters Recalled Due to Faulty Settings,Around 500 glucose meters from Nipro Diagnostics have been found to display glucose readings in mmol/L rather than the correct mg/dL used in the United States.
January 2014 ,News Alerts,FDA Issues Safety Warning for Sodium Phosphate,The FDA has warned that using more than 1 dose in 24 hours of over-the-counter sodium phosphate drugs to treat constipation can cause 'serious harm.'
January 2014 ,Reuters Health Information,Repeat Radiation Helps Ease Pain of Bone Metastases,"Patients with painful bone metastases have a good chance of benefiting from a second round of palliative radiation, regardless of treatment schedule, according to a new randomized controlled trial."
January 2014 ,Reuters Health Information,"Methotrexate Side Effects, Intolerance in Arthritis Patients","Rheumatoid arthritis and psoriatic arthritis patients commonly develop gastrointestinal side effects and intolerance to methotrexate therapy, researchers from the Netherlands report."
December 2013 ,Medscape Medical News,Pharmacists Lead Attack On 'Hidden Epidemic' of Hypoglycemia,BJC HealthCare's interventions cut adverse events by 2100 and saved the hospital system $7 million.
December 2013 ,Medscape Medical News,Taking Acid Inhibitors Long-term May Lead to B12 Deficiency,"Long-term proton pump inhibitor use is strongly associated with vitamin B12 deficiency, according to a Kaiser Permanente study."
December 2013 ,Medscape Medical News,"Pediatric Drug Labeling Slow to Follow Law, Study Finds ","Most neonatal prescribing is still off-label, despite legislation."
December 2013 ,Reuters Health Information,FDA Staff Cautious on Diabetes Drug Dapagliflozin,U.S. Food and Drug Administration staff said on Tuesday they were wary about the benefits versus the risks of AstraZeneca and Bristol-Myers Squibb's new diabetes drug dapagliflozin.
December 2013 ,News Alerts,Capecitabine Linked to Potentially Fatal Skin Reactions,"According to the manufacturer, capecitabine has been linked to severe and potentially fatal skin reactions."
November 2013 ,Reuters Health Information,Orexigen Diet Drug Does Not Increase Heart Risks,Orexigen Therapeutics Inc said study data showed its experimental obesity drug Contrave (bupropion/naltrexone) did not increase heart-related risks.
November 2013 ,Medscape Medical News,Fluoroquinolones Not Linked to Retinal Detachment,"Any differences in absolute risk between patients receiving fluoroquinolone compared with control patients are likely to have limited, if any, clinical significance. "
November 2013 ,Medscape Medical News,Advocates Lobby for Continued Access to Ponatinib in US,Cross-reactivity of allergens in pollens and foods can go haywire with ACE inhibitors.
November 2013 ,Medscape Medical News,Allergies and ACE Inhibitors a Dangerous Combination,Critically ill patients are 10 times more likely to have indeterminate results.
November 2013 ,Medscape Medical News,Penicillin Skin Test Not Recommended in Intensive Care,"The multicenter study joins the ranks of ONTARGET and ALTITUDE, 3 trials stopped early over safety concerns."
November 2013 ,Medscape Medical News,NEPHRON-D Ends Combination Therapy for Diabetic Nephropathy,"In clinical practice, the risk for venous thromboembolism (VTE) 3 months after the start of chemotherapy is about double that seen in clinical trials."
November 2013 ,Medscape Medical News,VTEs With Chemo 'Much Higher' in Real World Than in Trials,"Emergency department visits among infants resulting from cough and cold medicines have declined since product withdrawals and relabeling, according to a new CDC study."
January 2014 ,Medscape Medical News,Psychotropics Widely Prescribed for Intellectually Disabled,"The number of antipsychotic prescriptions for the intellectually disabled and those with mental health disorders does not differ much, but the overall number for both groups is still substantial."
January 2014 ,Medscape Medical News,Culinary Culprits: Foods That May Harm the Brain,"A growing body of research suggests there is a strong link between mood and food, with inflammation and even gut microbiota seen as mechanistic factors."
January 2014 ,Medscape Medical News,Peanut Allergy Effectively Countered With Oral Immunotherapy ,A phase 2 trial evaluating the use of oral immunotherapy for childhood peanut allergy has found that the approach benefited as many as 91% of children.
January 2014 ,Medscape Medical News,Quality of Life Declines With Androgen Deprivation Therapy,"Effects seem to resolve within 24 months, investigators say."
January 2014 ,Medscape Medical News,Sublingual Ragwitek Backed FDA Panel for Ragweed Allergy,"FDA panel recommends Ragwitek as sublingual immunotherapy for ragweed allergy, but with reservations about age of coverage."
January 2014 ,Medscape Medical News,Enzalutamide Before Chemo Slows Metastatic Prostate Cancer,There is now updated data on use of the androgen receptor blocker in men with metastatic disease who have progressed on androgen deprivation therapy but are chemotherapy-naive.
January 2014 ,Medscape Medical News,Hypomania: Can Antidepressants Be Reintroduced?,Antidepressant-associated hypomania did not recur during a 3-year follow-up after antidepressant treatment resumed without a mood stabilizer.
January 2014 ,Heartwire from Medscape,Evolocumab Lowers LDL in Statin-Intolerant Patients,"Evolocumab, an investigational PCSK9 inhibitor, successfully lowered LDL-cholesterol levels from baseline to week 12 in patients unable to tolerate statins because of side effects."
January 2014 ,Medscape Medical News,Smoking Causes Diabetes; Doctors Should Help Patients Quit,"The new US Surgeon General's report cites, for the first time, evidence for a direct causal link between smoking and diabetes, further highlighting the importance of clinical cessation efforts. "
January 2014 ,Reuters Health Information,Neuromyelitis Optica: What Immunosuppressive Agent Is Best?,"Rituximab and mycophenolate are superior to azathioprine for treatment of neuromyelitis optica (NMO), a comparative analysis shows."
January 2014 ,Medscape Medical News,The Good News on Antiamyloid Alzheimer's Therapies,"The trials of bapineuzumab and solanezumab in Alzheimer's were disappointing, but the studies, published now in New England Journal of Medicine, provide direction for the next round of research."
January 2014 ,Medscape Medical News,"In-Hospital Adverse Events Decline, But Not Across the Board","Adverse event rates decline for acute myocardial infarction and congestive heart failure, but not for pneumonia or surgeries."
January 2014 ,Medscape Medical News,Top 5 Pain Interventions to Avoid,First-line use of opioids for chronic noncancer pain is among the American Society of Anesthesiologists 'Choosing Wisely' list of questionable pain relief strategies.
January 2014 ,Medscape Medical News,Synthetic Marijuana 'Spice' Linked to Stroke,"Recreational use of the synthetic marijuana compound 'spice' may be linked to ischemic strokes in young, otherwise healthy individuals."
January 2014 ,Reuters Health Information,Nasal Packing Not Linked With Cardiopulmonary Complications,"Nasal packing to lower the risk of post-op bleeding and adhesions after septoplasty doesn't appear to cause cardiopulmonary complications, according to a new meta-analysis."
January 2014 ,Medscape Medical News,Chinese Herbs Reduce Progression to Diabetes by a Third,"Tianqi, a capsule combination of 10 Chinese medicinal herbs, reduced progression from impaired glucose tolerance to type 2 diabetes by 32% over 12 months."
January 2014 ,Medscape Medical News,Alemtuzumab Investigators Protest FDA Decision ,"Several multiple sclerosis experts involved in clinical development of alemtuzumab (Lemtrada, Genzyme) have voiced disappointment and frustration over the recent FDA decision not to approve the drug. "
January 2014 ,Medscape Medical News,'Suicide Test' May Aid Antidepressant Decision Making,A US company is developing a genetic test aimed at helping doctors identify patients at increased risk for suicide when antidepressant medications are prescribed.
January 2014 ,Medscape Medical News,New Parkinson's Gene Therapy Shows Promise ,"A new approach to gene therapy for Parkinson's disease has shown promising results in a phase 1/2 study, with no major safety issues and some improvement in motor symptoms in all 15 patients treated. "
January 2014 ,Medscape Medical News,Off-Label Use of Drugs Found Safe in ICU,"Using prescription drugs for purposes outside of their intended indication is not a cause for concern in the intensive care unit (ICU), say researchers."
February 2014 ,Medscape Medical News,FDA Panels: Primatene HFA Inhaler Not Recommended for Asthma,Panel members took some issue with over-the-counter availability as a replacement for appropriate medical care.
February 2014 ,Medscape Medical News,BP Meds Linked to Serious Fall Injuries in Elderly,Researchers call for consideration of harms vs benefits for individual patients.
February 2014 ,Heartwire from Medscape,Vegetarian Diet Cuts Blood Pressure in Meta-Analysis,"An analysis found consistent blood-pressure reductions, both in clinical trials and observational studies, that were roughly half of what can be seen with drugs, but with ""desirable"" side effects."
February 2014 ,Reuters Health Information,Pregnancy Not the Best Time to Lose Weight: Study,"Overweight and obese women who gain too few pounds, or even lose weight, during pregnancy may be putting their unborn child at risk, a new study suggests."
February 2014 ,Reuters Health Information,High-Dose Vitamin D Supplements May Benefit People With Chronic Urticaria,"People plagued by chronic urticaria (hives) may benefit from high-dose daily vitamin D supplements, new research suggests."
February 2014 ,International Approvals,Vokanamet Recommended by EMA for Type 2 Diabetes,"The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended canagliflozin/metformin (Vokanamet, Janssen-Cilag International NV) for type 2 diabetes."
February 2014 ,International Approvals,CHMP Backs Elosulfase Alfa for Rare Morquio A Syndrome,"Elosulfase alfa (Vimizim), approved earlier this month in the United States, replaces a missing enzyme that plays a key role in the rare, autosomal recessive lysosomal storage disease. "
February 2014 ,Medscape Medical News,Dramatic Results With CARs in B-Cell Leukemia ,Results from 16 patients with B-cell acute lymphoblastic leukemia show a complete remission rate of 88% after infusions of modified T-cells.
February 2014 ,Medscape Medical News,Radiation-Free Imaging Technique Breaks New Ground,A radiation-free alternative for staging malignant tumors in children and adolescents enhances MRI images with the iron supplement ferumoxytol.
February 2014 ,Medscape Medical News,Citalopram Reduces Agitation in Patients With Alzheimer's ,"Results of the CitAD trial show 30 mg daily moderates agitation in AD but also affects cognition, can cause electrocardiography changes, and is no longer recommended in older adults."
February 2014 ,Medscape Medical News,Mom's Voice Helps Preemies Improve Feeding Skills,"Premature infants improved their oral feeding skills when given a pacifier-activated music device with their mother's voice, a randomized trial found."
February 2014 ,FDA Approvals,FDA Clears the First Drug for Rare Morquio A Syndrome,Elosulfase alfa (Vimizim) treats Morquio A syndrome by correcting a deficiency in an enzyme important for metabolism.
February 2014 ,FDA Approvals,Ibrutinib (Imbruvica) Approved for CLL in US,The first-in-class inhibitor of Bruton's tyrosine kinase has been described as a 'turning point' in the treatment of chronic lymphocytic leukemia (CLL).
February 2014 ,Reuters Health Information,Fixed-Dose Rituximab Provides Durable Remission of Pemphigus,"Fixed-dose rituximab therapy can produce durable remission of pemphigus, a retrospective study suggests."
February 2014 ,News Alerts,FDA Reviewing Saxagliptin Trial Data for Possible HF Risk,The FDA issued a communication this morning stating it has requested the trial data from the manufacturer so that it can investigate a possible association between the use of saxagliptin and heart-failure risk.
February 2014 ,Medscape Medical News,Heavy Psychotropic Med Burden Common in Bipolar Patients,"Many patients with bipolar disorder are being medicated with 4 or more drugs, including drugs for other psychiatric conditions."
February 2014 ,Medscape Medical News,European Approval for Tecfidera as First-Line in MS ,European regulators have approved dimethyl fumarate as first-line therapy in multiple sclerosis.
January 2014 ,Medscape Medical News,Long-term Data Show Ra-223 Safe in Advanced Prostate Cancer,"Radium-223 prolonged survival in castration-resistant prostate cancer, and safety data at 1.5 years show it to have minimal toxicity."
January 2014 ,Medscape Medical News,"Resistance, Aerobic Training May Reduce Pain in Fibromyalgia","Patients with fibromyalgia gained function, strength, and reduced pain and tenderness with resistance training. Aerobic training also reduced pain."
January 2014 ,Medscape Medical News,Teriflunomide Approved in UK for MS; TOWER Published,"The drug is the first oral agent for first-line use in patients with relapsing-remitting MS in the UK, and it may become a popular option for patients with mild disease. "
March 2014 ,Medscape Medical News,SBRT Cheaper but More Toxic Than IMRT for Prostate Cancer,"Stereotactic body radiotherapy (SBRT) is cheaper but more toxic than intensity-modulated radiotherapy (IMRT) for prostate cancer, according to a comparative study."
March 2014 ,Medscape Medical News,"Insulin-Related Hypoglycemia: Common, Costly, Preventable","Insulin-related hypoglycemia leads to thousands of visits to emergency each year, especially among elderly patients, a new report shows. This is far too common to be acceptable, says one expert."
March 2014 ,Medscape Medical News,No Difference by Injection Approach for Low Back Pain,"Despite widespread belief of improved pain relief with transforaminal injections, randomized trials show no significant differences for relief of radiating low back pain or for function."
March 2014 ,Medscape Medical News,TMS Relieves Symptoms in Teens With Resistant Depression,"Repetitive transcranial magnetic stimulation may be a useful therapy in teens with treatment-resistant depression, preliminary research suggests."
March 2014 ,Medscape Medical News,"Sherwin Nuland, MD, Clear-eyed Witness to Death, Dies at 83",The surgeon and author of 'How We Die' urged clinicians to level with dying patients about what they are facing and to know when to give up on life-prolonging treatment.
March 2014 ,News Alerts,PRAC Wants Restrictions on Domperidone Due to Cardiac Risks,"Reducing the recommended dose and duration of treatment with domperidone-containing antiemetics is key to minimizing its risks, the Committee said."
March 2014 ,News Alerts,"EMA Panel Says Diacerein Should Stay, but With Restrictions","After reexamining diacerein-containing medicines, an EU panel has recommended that these products remain available, although with restrictions to manage risks."
March 2014 ,Medscape Medical News,Vision Loss Reported After Cosmetic Facial Injections,"Dermal filler injections in the forehead led to vision loss, a rare but devastating event, in 3 patients."
March 2014 ,FDA Approvals,"FDA Approves Aveed Testosterone Jab, with Restrictions","The FDA has approved Aveed, a long-acting depot form of testosterone, after 3 previous rejections, stipulating a boxed warning in the label and stringent prescribing requirements."
March 2014 ,News Alerts,Nationwide Recall of Antidepressant Issued,A nationwide recall of 3 different lots of the antidepressant Effexor has been issued by the drug's manufacturer due to possible contamination with a heart drug that could have fatal consequences.
March 2014 ,Medscape Medical News,Oral Immunotherapy Reduces Sensitivity to Dust Mites,"An experimental sublingual tablet cut nasal symptoms by half and conjunctivitis by two thirds in early investigation, say researchers."
March 2014 ,Medscape Medical News,No Benefit to Earlier Use of Bone Drug in Prostate Cancer,"Use of zoledronic acid for castration-sensitive prostate cancer does not decrease the risk for skeletal events, compared with treatment started after progression to castration-resistant disease."
March 2014 ,Medscape Medical News,Memantine Discontinuation Rates Underestimated in Research?,Randomized clinical trials may underestimate the rate of memantine discontinuation and dose reductions in dementia patients.
March 2014 ,Reuters Health Information,"Italian Watchdog Says Novartis, Roche Colluded Over Eye Drug","Italy's antitrust authorities said Novartis and Roche colluded to try to stop cancer drug Avastin (bevacizumab) from being used to treat a serious eye disease, and fined the Swiss drugmakers 182.5 million euros ($251 million)."
March 2014 ,Medscape Medical News,Excellent Outcomes With Proton Therapy in Prostate Cancer,A new study shows extremely high efficacy in 5-year outcomes for prostate cancer patients in all risk categories.
March 2014 ,Medscape Medical News,"Hypoglycemia Begets More Hypoglycemia, New ASPIRE Data Find","New analysis of the ASPIRE study of an insulin-delivery system's ""threshold-suspend"" function finds that the ability to ameliorate hypoglycemia is impaired by prior hypoglycemia."
March 2014 ,Medscape Medical News,New Interferon-Free Drugs for Hep C Show High Cure Rates,"Interferon has been the primary treatment for chronic hepatitis C for 2 decades, but new drugs promise better results with fewer adverse effects."
March 2014 ,Medscape Medical News,Provaccine Messages May Backfire Among Parents,Researchers have found that current public health messages may be reducing the misperception about vaccines and autism but not increasing intent to vaccinate future children.
March 2014 ,Heartwire from Medscape,Single-Patient Studies Test Statin-Related Myalgia,"When exposing eight patients to several double-blind statin and placebo challenges, none had a statistically significant difference in myalgia or other pain measures on the statin compared with placebo."
February 2014 ,Medscape Medical News,Improving QOL in Head and Neck Cancer as Survival Improves,Reducing radiation doses to organs not affected by cancer is becoming increasingly important as these patients are diagnosed at a younger age.
March 2014 ,Medscape Medical News,All That Glitters Is Not Gold: AleCardio Dissected at ACC,Presentation of the AleCardio trial results at ACC provides a few more clues as to why the dual PPAR agonist aleglitazar has become the latest in a line of these agents to fail spectacularly.
March 2014 ,Medscape Medical News,Nintedanib: New Oral Angiogenesis Inhibitor in Lung Cancer ,"When added to docetaxel in second-line therapy, the new agent improved survival in a subgroup of patients with adenocarcinoma histology."
March 2014 ,Medscape Medical News,"ECT: Electrode Placement, Age Influence Depression Outcomes","In individuals with severe depression who are treated with ECT, electrode placement and patient age may have a significant influence on treatment outcomes."
March 2014 ,Medscape Medical News,Culture Change Needed to Combat ICU Delirium,"A new study underscores the role of sedatives in delirium in the ICU, but surprisingly, no link was seen between sleep quality and delirium risk."
March 2014 ,Medscape Medical News,"Unlike FDA, Europe Does Not Like Melanoma Combo Yet","The combination of trametinib and dabrafenib was approved by the FDA in January, but a European regulatory committee feels differently."
March 2014 ,Medscape Medical News,New Agent Offers Promise for ALK-Positive NSCLC,"Ceritinib, a new targeted therapy, has demonstrated effectiveness in this patient subgroup, even in those who have progressed on crizotinib."
March 2014 ,Reuters Health Information,Sanofi Faces Make-or-Break Verdict on Big Dengue Vaccine Bet, Sanofi expects final clinical results for its vaccine against dengue by late September and has already gambled on starting production despite some disappointing early trials data.
March 2014 ,Medscape Medical News,ASCO Updates Node Dissection Early Breast Cancer Guideline,"Many women with early-stage breast cancer can avoid the more invasive axillary lymph node dissection, and instead have sentinel node biopsy, which has fewer complications."
March 2014 ,Medscape Medical News,"New AAN Guideline on Cannabis, Alternative Medicine in MS",The guideline gives some support to cannabis products but emphasizes there is little evidence for most complementary and alternative medicine in multiple sclerosis.
March 2014 ,Reuters Health Information,Poor Long-Term Survival After ICU Acute Kidney Injury,"Long-term survival remains poor after acute kidney injury (AKI) in the intensive care unit, but most of those who do survive don't need maintenance dialysis."
March 2014 ,Reuters Health Information,Vismodegib Shrinks Keratocystic Odontogenic Tumors,"The oral Hedgehog pathway inhibitor vismodegib shrinks keratocystic odontogenic tumors (KCOTs) in patients with basal cell nevus syndrome (BCNS), according to results from a small clinical trial."
March 2014 ,Medscape Medical News,SSRI May Negatively Affect Male Fertility,"The SSRI sertraline may have a negative impact on some semen parameters, a finding that may have implications for male fertility."
March 2014 ,FDA Approvals,FDA Clears IV Formulation of Antifungal Posaconazole ,"Posaconazole (Noxafil) is now available in delayed-release tablets, oral suspension, and intravenous formulations. "
March 2014 ,Medscape Medical News,Something in the Air? Ambient Lead Linked to Alzheimer's,Even exposure to very low levels of ambient lead may increase the risk for Alzheimer's disease in patients with amnestic mild cognitive impairment.
March 2014 ,FDA Approvals,FDA OKs Propranolol Hydrochloride for Infantile Hemangioma,Hemangeol is the first and only pediatric oral formulation of propranolol hydrochloride for treatment of proliferating infantile hemangioma requiring systemic therapy.
March 2014 ,Medscape Medical News,"After Metformin, Are Newer Drugs Better for Type 2 Diabetes?","A new analysis based on claims data suggests that sulfonylureas perform just as well as newer agents for second-line treatment of type 2 diabetes, but at far lower cost."
March 2014 ,Medscape Medical News,Penicillin 'Allergy' History May Be Inaccurate and Costly ,"Penicillin 'allergy' history is often inaccurate but is linked to longer hospital stay, significantly more antibiotic use, and increased C difficile, MRSA, and VRE prevalence. "
March 2014 ,Medscape Medical News,Viral Hepatitis Meeting a Must for Healthcare Providers,The conference to be held at Mount Sinai in New York City will offer not-to-be missed talks on recent developments in hepatitis C treatment.
March 2014 ,Heartwire from Medscape,Obesity's Genetic Trick Might Protect Against Its Ills,"Rising body-mass index seems to influence the switching mechanism of a gene with downstream physiologic effects, in one of the most extensive epigenetic studies of obesity to date."
March 2014 ,Heartwire from Medscape,The 'Real' Side-Effect Cost of Statins: Sorting Fact from Fiction,"In primary prevention, the risk of developing diabetes with statins is real, but just one in five cases of new-onset diabetes are caused by the drugs. In secondary prevention, the risk is offset by the reduction in cardiovascular deaths."
April 2014 ,Medscape Medical News,ASCO Launches New Survivorship Guidelines,ASCO has launched the first 3 guidelines as part of a series that will cover all aspects of cancer survivorship.
April 2014 ,Medscape Medical News,Serious Side Effect Seen in MS Patients on Interferon Beta,"Unexpected cases of thrombotic microangiopathy have emerged in patients with MS taking a relatively new formulation of interferon beta in one report, but cases have been reported with all brands."
April 2014 ,Medscape Medical News,Novel Nonopioid Approach Promising for Opioid Dependence,"The combination of a muscle relaxant, an antihistamine, and an anticonvulsant may be a better way to detox opioid-dependent patients than a protocol that involves buprenorphine/naltrexone."
April 2014 ,FDA Approvals,FDA OKs Sublingual Grastek for Timothy Grass Pollen Allergy,"The FDA approved a grass pollen allergen extract for the treatment of Timothy grass pollen-induced allergic rhinitis, with or without conjunctivitis, in individuals aged 5 to 65 years."
April 2014 ,Medscape Medical News,Lung Cancer: A Dose-Dependent Risk After Breast Cancer RT,"The risk of developing a primary lung cancer after radiotherapy for breast cancer increases in a dose-response manner, with these odds jumping 17-fold in smokers."
April 2014 ,Medscape Medical News,Ocular Effects Common After Childhood Bone Marrow Transplant,"Children who undergo bone marrow transplantation can suffer ocular complications, such as cataract and dry eye syndrome, which can be long lasting and require treatment into adulthood."
April 2014 ,Heartwire from Medscape,Calcium/CVD Risk Debate Gets New Fodder From Analysis,The meta-analysis contradicts previous studies suggesting that calcium supplements could increase the risk of MI.
April 2014 ,Medscape Medical News,Mechanism for Ipilimumab Pituitary Toxicity Identified,"Expression of CTLA-4 on pituitary endocrine cells could underlie hypophysitis secondary to CTLA-4 blockade with ipilimumab, which has implications for care. "
April 2014 ,Medscape Medical News,ED Drugs Linked to Increased Melanoma Risk,Data from the Health Professionals' Follow-up Study show a strong association between sildenafil use and melanoma risk.
April 2014 ,Medscape Medical News,"VEGF Inhibitors Safe for AMD, Despite Expectations","In patients with age-related macular degeneration (AMD), cardiovascular risks might be more strongly associated with age than with vascular endothelial growth-factor (VEGF) inhibitors."
April 2014 ,Medscape Medical News,Transcranial Stimulation in Disorders of Consciousness,"A short session of transcranial direct-current stimulation over the left dorsolateral prefrontal cortex may result in clinical improvement for patients in a minimally conscious state, early findings show."
April 2014 ,Medscape Medical News,NIMH Tightens Up Funding Criteria for Clinical Trials,"In an effort to improve the development of treatments for psychiatric disorders, the NIMH has changed its funding policies for future clinical trials, including timelier reporting of results."
April 2014 ,Medscape Medical News,First-in-Class Defibrotide for VOD Launched in Europe,"Defibrotide, a drug used to treat severe veno-occlusive disease (VOD), a life-threatening complication related to hematopoietic stem cell transplantation, has been launched in Europe."
April 2014 ,Medscape Medical News,ASCO's New Strategy to Define 'Value' in Cancer Care,"Under the leadership of the Value in Cancer Care Task Force, ASCO has launched a strategic initiative to define value in cancer care."
April 2014 ,Medscape Medical News,Pharmacists Well Placed to Educate About Dietary Supplements,"Pharmacists can educate people about widely used dietary supplements that could be harmful, especially when used in the presence of certain chronic health conditions."
April 2014 ,Heartwire from Medscape,Darapladib Fails to Reduce CVD Risk in STABILITY,"pproximately one in five patients treated with darapladib stopped taking the investigational Lp-PLA2 inhibitor because of adverse effects, including malodorous feces, urine, and skin."
April 2014 ,Medscape Medical News,Hepatitis C Drug Trials to Take Spotlight at Liver Congress,The European Association for the Study of the Liver International Liver Congress 2014 will feature phase 3 data on all-oral regimens for hepatitis C.
April 2014 ,Medscape Medical News,"Methotrexate Decreases Pain, Improves Function in Knee OA","Methotrexate, which is widely used for rheumatoid arthritis, also reduced pain and improved function in patients with knee osteoarthritis in a randomized controlled trial. "
March 2014 ,Reuters Health Information,Gilead Has Discounted HCV Drug for Some Health Plans,"Gilead Sciences Inc, under fire for pricing a new hepatitis C drug at $1,000 a pill, has discount agreements with a number of health insurers, a company executive said in an interview."
March 2014 ,Medscape Medical News,Heart-Failure Data for Alogliptin Prompt More Debate at ACC,"The possible risk of heart failure associated with the use of the dipeptidyl peptidase-4 inhibitor drugs for type 2 diabetes is once again in the spotlight, with new data from the ACC meeting."
May 2014 ,Medscape Medical News,TMS Cost-effective for Resistant Depression,"An economic analysis suggests transcranial magnetic stimulation is ""good value for money"" in patients with antidepressant-resistant major depression."
May 2014 ,Medscape Medical News,NSAID Monotherapy Prevents Postsurgery Cystoid Macular Edema,"Bromfenac monotherapy prevented cystoid macular edema after cataract surgery better than a steroid plus an NSAID, in a 5-year analysis."
May 2014 ,Medscape Medical News,Online Sex Supplements Linked to Serious Psychoactive Effects,"Ingredients found in sexual enhancement products sold online, such as yohimbine and horny goat weed, have been linked to several psychoactive effects, including anxiety, panic, and hallucinations."
May 2014 ,Medscape Medical News,Nonstimulant May Provide Rapid Relief for Adult ADHD,An extended-release formulation of the nonstimulant metadoxine improves attention after a single dose in adults with predominantly inattentive ADHD.
May 2014 ,Medscape Medical News,TMS Promising for Generalized Anxiety,"Repetitive transcranial magnetic stimulation appears to be a promising treatment for patients with generalized anxiety disorder, a frequently chronic condition characterized by debilitating worry."
May 2014 ,Medscape Medical News,FDA Panel Rejects OTC Use of Montelukast (Singulair Allergy),The FDA advisory committee has recommended against use of partial expansion of montelukast for OTC use against allergic rhinitis.
May 2014 ,News Alerts,"Ranbaxy Recalls Nearly 30,000 Packs of Allergy-Relief Drug in US","Indian drugmaker Ranbaxy Laboratories started recalling 29,790 packs of an allergy-relief medicine in the US in February after finding defects in the packaging."
April 2014 ,Reuters Health Information,Glucantime Side Effects in Leishmaniasis Not Worse in Children,"Cutaneous leishmaniasis treatment with systemic meglumine antimoniate (Glucantime, Sanofi Aventis) is generally fairly well tolerated in children and the rate of adverse events is similar to that seen in adults."
May 2014 ,Medscape Medical News,Pixantrone a 'Milestone' for Aggressive Relapsed B-cell NHL,Patients with aggressive B-cell non-Hodgkin's lymphoma (NHL) who have failed after second-line therapy have few options: now pixantrone can be used in Europe.
April 2014 ,Medscape Medical News,'Low-Risk' Kidney Stone Removal May Be Risky and Costly,"After low-risk procedures to remove urinary stones, patients often need an unplanned emergency visit at substantial cost, suggesting a need for interventions to identify and reduce complications. "
April 2014 ,Reuters Health Information,Benefits of Delayed Umbilical Cord Clamping Gone by 12 Months,"Early benefits of delayed umbilical cord clamping (DCC) on iron stores seem to have disappeared by the time infants are one year old, researchers from Sweden report."
April 2014 ,Medscape Medical News,AWARD-5: Dulaglutide Betters Sitagliptin in Type 2 Diabetes,"In patients with type 2 diabetes uncontrolled with metformin, adding weekly injections of dulaglutide led to better glycemic control at 1 year compared with adding oral sitagliptin, with acceptable safety."
April 2014 ,News Alerts,Domperidone Restrictions Endorsed in EU Due to Cardiac Risk,An EMA committee has confirmed recommendations to restrict the use of domperidone-containing antiemetics because of concerns about adverse cardiac effects.
April 2014 ,Medscape Medical News,Novel Agents for Migraine Prevention Look Good in Phase 2,Two new agents representing a novel mechanism of action for the prevention of migraine are generating much interest after showing promising results in phase 2 studies.
April 2014 ,Medscape Medical News,FDA Considers Ban on 'Noxious' Devices for Behavior Control,The FDA is considering a complete ban on aversive electrical stimulation devices to control unwanted behaviors.
April 2014 ,Medscape Medical News,"Gastric Bypass: Appetite Drop, Food Aversion Common Afterward"," Moreover, patients who lose their taste for certain foods--typically meat--are more likely to attain greater weight loss, researchers report."
April 2014 ,News Alerts,Spinal Corticosteroids Run Risk of Severe Neuro Effects,"The FDA has announced that injections given to treat neck and back pain and radiating pain in the arms and legs may result, on rare occasions, in blindness, stroke, paralysis, and death. "
April 2014 ,Medscape Medical News,Effects of Childhood Bullying Persist Well Into Adulthood,"Adults who were frequently bullied in childhood continue to be at risk for poorer mental, physical, and social health 4 decades later."
April 2014 ,Reuters Health Information,Exemestane Well-Tolerated for Breast Cancer Prevention,"When given to prevent breast cancer in postmenopausal women, the aromatase inhibitor exemestane has little effect on quality of life, according to follow-up results of the MAP.3 trial."
April 2014 ,Medscape Medical News,"In Prostate Hyperplasia, Combo Pill Slows Progress","Men with moderate symptoms of benign prostate hyperplasia treated with dutasteride plus tamsulosin hydrochloride fared better than those monitored with watchful waiting, new research shows."
May 2014 ,Medscape Medical News,Psyllium as Effective as Loperamide for Fecal Incontinence,"Episodes of fecal incontinence can be nearly halved with either psyllium fiber or loperamide, a crossover placebo-controlled trial has shown."
May 2014 ,Heartwire from Medscape,Specialized Clinic Gets Results in Resistant Hypertension,"The clinic, which includes a dietician, nurse practitioners, and physicians, including cardiologists and nephrologists, saw patients reduce their systolic BP from 153 mm Hg to 130 mm Hg."
May 2014 ,Medscape Medical News,Drug Reactions More Likely in Kids With Complex Conditions,Children with complex chronic conditions were 4 times as likely to visit the emergency department for an adverse drug event as other children.
May 2014 ,Medscape Medical News,High Dropout Rate in Active Surveillance for Prostate Cancer,A real-world study of men with prostate cancer indicates that more than one third of men who undergo active surveillance drop out.
May 2014 ,Reuters Health Information,Pre-praziquantel Snack Beneficial in Childhood Schistosomiasis,"Giving a snack prior to praziquantel treatment improved compliance and reduced the burden of schistosomiasis among children in Uganda, according to a new study."
May 2014 ,Heartwire from Medscape,BMJ Withdraws Statement on Statin-Related AEs,"Two research papers erroneously cited that 20% of patients develop statin-related adverse events, a figure that is based on observational data. These statements have been withdrawn and BMJ will review next steps."
May 2014 ,Medscape Medical News,"Don't Treat Early-Stage Prostate Cancer in Older, Sicker Men","Older men diagnosed with early-stage prostate cancer who have pre-existing medical conditions, such as diabetes, COPD, and heart disease, derive no survival benefit from aggressive treatment."
May 2014 ,Medscape Medical News,Appears Safe to Delay ADT When Prostate Cancer Recurs,Delaying androgen-deprivation therapy in men who have biochemical recurrence of prostate cancer did not affect survival in a new study.
May 2014 ,Medscape Medical News,"New Glatiramer Dosing Convenient, Possibly Safer, in MS","Patients with relapsing-remitting multiple sclerosis who inject glatiramer acetate 3 times a week instead of daily experience fewer injection site reactions and may, over time, avoid lipoatrophy."
May 2014 ,Medscape Medical News,Intensive Pain Rehab Improves Kids' Mental Health,An intensive interdisciplinary pain rehabilitation program that focuses on the individual needs of each child improves psychological functioning in kids with a variety of pain conditions.
May 2014 ,Medscape Medical News,IL-2 for Kidney Cancer Offers Cure,"High-dose interleukin-2 is still a viable treatment option for metastatic renal cell carcinoma, because it is the only truly curative option for advanced disease."
May 2014 ,Reuters Health Information,Brodalumab Meets Goals in Phase 3 Psoriasis Study,"A drug under development by Amgen Inc and AstraZeneca Plc met the goals of a Phase 3 study in patients with moderate-to-severe plaque psoriasis, the companies said on Friday."
May 2014 ,Reuters Health Information,Dual Therapy Effective in Newly Diagnosed HIV-1 Infection,"In previously untreated adults with HIV-1 infection, dual therapy with lopinavir and ritonavir plus lamivudine is as effective as triple therapy with lopinavir and ritonavir plus two NRTIs."
May 2014 ,Medscape Medical News,Parathyroid Hormone for Hypoparathyroidism: More Data,"Further phase 3 trial results of recombinant human parathyroid hormone in patients with hypoparathyroidism show that almost all can cut out vitamin D, and 58% eliminate both calcium and vitamin-D supplements."
May 2014 ,Medscape Medical News,Macular Thinning on Fingolimod Treatment in MS,A recent study shows a decrease in macular volume with 1 year of treatment of patients with MS receiving fingolimod. Whether this decrease correlates with a loss of brain volume is not yet known.
May 2014 ,Medscape Medical News,Thromboprophylaxis in Cancer Patients: Needs Rethink,"Most hospitalized cancer patients receive thromboprophylaxis, but clinicians urgently need better tools for determining which cancer patients are likely to benefit."
May 2014 ,Medscape Medical News,Dabigatran Crosses Placenta in Ex Vivo Experiment,"With ex vivo data showing dabigatran can cross the placenta, its safety during pregnancy is questionable, researchers say. "
May 2014 ,Medscape Medical News,"Ondansetron, Metoclopramide Similar in Head-to-Head Trial",Ondansetron is more expensive but no better than metoclopramide in treating morning sickness in pregnant women; women taking metoclopramide reported more minor adverse effects.
May 2014 ,Medscape Medical News,Hospital-Acquired Conditions and Readmits on Downswing,"Medicare readmissions decreased again in 2013, and fewer hospital-acquired infections, falls, and drug mishaps in 2011 and 2012 saved almost 15,000 lives, according to HHS."
May 2014 ,Heartwire from Medscape,Salt and Battery: Debate on Sodium Targets Gets Feisty," The PURE study suggests that low sodium intake is linked with increased cardiovascular risks, but the question of sodium targets is far from settled, with a corresponding debate on the topic getting oddly personal."
May 2014 ,Reuters Health Information,Methylprednisolone to Reduce Strictures After Esophageal Burns ,"High doses of methylprednisolone can reduce stricture formation after esophageal burns in children who ingest caustic substances, researchers from Turkey report."
June 2014 ,Heartwire from Medscape,TESLA: Evolocumab Clears Hurdle in Homozygous FH," Added on top of a statin and ezetimibe, evolocumab reduced LDL cholesterol 23% compared with an 8% increase among the placebo-treated patients. Experts hope the drug class can be used for hard-to-treat HoFH patients."
June 2014 ,Medscape Medical News,Targeted Drug Combo Improves Outcomes in Ovarian Cancer,"The combination of 2 investigational drugs, olaparib and cediranib, holds promise as a nonchemotherapy approach to ovarian cancer."
June 2014 ,Medscape Medical News,Sunday at ASCO: Hot News From Plenary Session,"The plenary session today will hear potentially practice-changing results in breast and prostate cancer, and reassuring results in colorectal cancer. "
May 2014 ,Medscape Medical News,Friday at ASCO: Improving Quality of Life,"Oncology is not just about helping people to live longer, but also involves strategies that will improve patients' quality of life, says ASCO expert."
May 2014 ,FDA Approvals,FDA Okays First Device for Restless Legs Syndrome ,"The FDA will allow marketing of the Relaxis pad (Sensory Medical Inc), a nonpharmacologic approach to improve sleep quality in RLS."
May 2014 ,Medscape Medical News,Exercise Benefits of Caffeine Might Be Genetic,"Caffeine helps sedentary people become more active, but genetic differences could determine who will get an athletic boost, a pair of studies suggest."
May 2014 ,Medscape Medical News,Acute Radiation Skin Toxicity Possible With BRAF Inhibitors,"Five cases point to a potential unanticipated interaction between BRAF inhibitors and ionizing radiation, leading to acute skin toxicity."
May 2014 ,Medscape Medical News,Physical Therapy May Not Be Helpful for Osteoarthritis ,Physical therapy for patients with hip osteoarthritis was associated with mild temporary increases in pain in the hip or back that tended to resolve over time.
May 2014 ,Medscape Medical News,Tamoxifen for 10 Years an Option: ASCO Guideline Update,"Women with hormone receptor-positive breast cancer should consider taking tamoxifen for 10 years, ASCO says."
May 2014 ,Medscape Medical News,Nintedanib Slows Idiopathic Pulmonary Fibrosis Progression,"The tyrosine kinase inhibitor slowed the decline in lung function over a year in 2 phase 3 trials, providing hope for another therapeutic option for these patients."
May 2014 ,Medscape Medical News,Diabetes Drug Eyed as Obesity Treatment,"Already approved for the treatment of diabetes, the incretin mimetic liraglutide is now being investigated as a potential weight-loss drug."
May 2014 ,FDA Approvals,FDA Clears Dalbavancin (Dalvance) for Acute Skin Infections,The antibacterial agent is the first designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval.
May 2014 ,Medscape Medical News,Few Hospices Providing CAM Services to Patients,"Only 29% of hospices in the United States employ complementary and alternative medicine (CAM) therapists for massage, music, or art therapy, despite the growing interest in these services."
May 2014 ,International Approvals,"CHMP Endorses Peginterferon-Beta-1a, Not Laquinimod, in MS","After a second look at laquinimod, the EMA panel maintains that the benefits don't outweigh the potential risks of the drug. "
May 2014 ,State Health Alerts,PFOS Detected in Pease Tradeport Water System, A new series of articles in Epilepsia examine the potential use of cannabidiol and medical marijuana in young patients with epilepsy.
May 2014 ,Medscape Medical News,Experts Debate Use of Cannabis to Control Seizures,"When it comes to EHR adoption, physicians in large practices are outpacing soloists. The gap between primary care physicians and specialists has grown as well."
May 2014 ,Medscape Medical News,"EHR Divide Is Widening Among Physicians, CDC Says","Even a single episode of binge drinking can cause bacterial leakage from the gut, which in turn can lead to the release of endotoxins in the bloodstream."
May 2014 ,Medscape Medical News,Single Binge Drinking Episode Drives Systemic Toxicity,"A fifth of older people hospitalized for hypoglycemia will have died within a year, say the authors of a newly published study; they call for diabetes treatment goals to be softened in these patients."
June 2014 ,Heartwire from Medscape,Sausage Link? Heart-Failure Risk Higher with Processed Meats ,"That's not the wurst of it. While the incident heart-failure risk went up significantly with consumption of any form of processed meat, so did the risk of heart-failure death--and more sharply."
June 2014 ,Medscape Medical News,"Marijuana Tied to Addiction, Long-term Cognitive Dysfunction","Marijuana use is linked to several adverse effects, including addiction and long-term cognitive dysfunction."
June 2014 ,Medscape Medical News,New ACS Guide for PCPs Managing Prostate Cancer Survivors,Detailed guidelines advise primary care physicians on medical and psychosocial aspects of survivorship.
June 2014 ,Medscape Medical News,Levodopa Best Choice for Initial Parkinson's Treatment,"The largest ever drug trial in Parkinson's disease found that levodopa beats dopamine agonists and monoamine oxidase type B inhibitors in terms of patient-reported mobility, quality of life, and other measures."
June 2014 ,FDA Approvals,FDA OKs First Topical Triazole Antifungal for Onychomycosis,Efinaconazole (Jublia) is the first triazole antifungal to be developed for the treatment of distal lateral subungual onychomycosis.
June 2014 ,FDA Approvals,FDA Approves Bunavail for Opioid Addiction,The FDA has approved a new drug for the maintenance treatment of opioid dependence.
June 2014 ,Medscape Medical News,What's Hot at EULAR 2014,"TNF-alpha inhibitors, biosimilars, and the IL-17 pathway are just a few of the topics on the EULAR program that have its scientific chair excited."
June 2014 ,Medscape Medical News,Naloxegol Reduces Opioid-Induced Constipation ,"A new study shows naloxegol, a member of a class of agents that decreases gastrointestinal adverse effects without affecting analgesia, increases bowel movements."
June 2014 ,Heartwire from Medscape,Few Breast-Cancer Patients With HF Referred to Cardiologists,"A new study puts the number of women with diagnosed HF or cardiomyopathy secondary to their breast-cancer treatments at 12%, yet only one-third are promptly referred for a cardiology workup."
June 2014 ,Medscape Medical News,Antidepressant-Related Weight Gain: Not All Agents Equal,Data for a 12-month period show modest differences in the amount of weight patients taking common antidepressant medications are likely to gain.
June 2014 ,Medscape Medical News,"Stopping Statins Safe, Cuts Costs, in Terminal Patients",About $600 million could be saved if statins were stopped in every patient with less than a year's life expectancy; a new study shows such discontinuation is safe.
June 2014 ,Medscape Medical News,"Air Pollution Linked to Mixed, Small Health Effects ",UK researchers have found 'no clear evidence' of possible links between ambient air pollution and cardiovascular deaths in England and Wales.
June 2014 ,Medscape Medical News,IV Theophylline Quickly Reduces Lumbar Puncture Headache,"A small study shows that the pain common after lumbar puncture or spinal anesthesia quickly resolves with IV theophylline, with the greatest relief in the first 30 minutes but continuing out to 60 minutes."
June 2014 ,Medscape Medical News,"TAC, AC+T Linked to Higher Toxicity in Early Breast Cancer","Early-stage breast cancer patients under 65 had more hospitalizations after TAC or AC+T than after standard TC, and older patients had more hospitalizations after any regimen other than ddAC+P."
June 2014 ,Medscape Medical News,Tapentadol is 'Third-Tier' Drug for Diabetic Neuropathic Pain,"Tapentadol improves the quality of life of patients with painful diabetic peripheral neuropathy, but because it is a narcotic and expensive, it is relegated to a third-tier treatment, says one expert."
June 2014 ,Medscape Medical News,Is Ipilimumab Useful for Earlier-Stage Melanoma?,A randomized placebo-controlled trial provides relapse-free survival results for patients with stage III disease.
June 2014 ,Medscape Medical News,Life-Threatening Adverse Drug Reactions Likely to Recur,"Two serious skin conditions, Stevens-Johnson syndrome and toxic epidermal necrolysis, are rare, but had a high recurrence rate in a population-based cohort study. "
June 2014 ,Medscape Medical News,Hope on Horizon for Newer Obesity Drugs in Europe?,The lack of obesity drugs in Europe was the focus of much discussion at the European Conference on Obesity last week. Hopes are high that bupropion/naltrexone and liraglutide will soon be approved there.
June 2014 ,Medscape Medical News,Novel Compound Shows Promise in Diabetic Nephropathy,Emapticap pegol showed significant and sustained anti-inflammatory effects in diabetic nephropathy in a phase 2 trial.
June 2014 ,FDA Approvals,"FDA OKs Aloxi for Chemo-Induced Nausea, Vomiting in Children","The FDA has approved palonosetron HCL (Aloxi, Eisai Inc and Hensinn Group) injection for the prevention of chemotherapy-induced nausea and vomiting in children aged 1 month to less than 17 years."
June 2014 ,Medscape Medical News,Ketamine Metabolite Has Promise in Depression,Hydroxynorketamine may treat symptoms of depression without ketamine's unwanted side effects and also shows potential in neurodegenerative diseases such as Alzheimer's and Parkinson's.
June 2014 ,Medscape Medical News,Psychotropic Drugs Can Reduce Bone Mass in Kids,A study has found that SSRIs and risperidone can have deleterious effects on bone mass formation and accrual in children who take these medications on a long-term basis.
June 2014 ,Medscape Medical News,More on HF Hospitalization With Gliptins in Type 2 Diabetes,A new post hoc analysis of the VIVIDD study with the DPP-4 inhibitor vildagliptin in patients with type 2 diabetes and heart failure has shown that the drug is not associated with an increase in hospitalizations for HF.
June 2014 ,Medscape Medical News,Third Meningococcal Vaccine Recommended for Children at Risk ,A third meningococcal vaccine is an additional option for children at increased risk for meningococcal disease.
June 2014 ,Reuters Health Information,A 4-Week Hep C Cure? Bristol to Test Drugs With Gilead's Sovaldi,"In the race to find a faster cure for hepatitis C, Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences Inc's blockbuster drug Sovaldi (sofosbuvir)."
June 2014 ,Medscape Medical News,Hospitalization Rates Drop With LAIs in Schizophrenia,Switching patients with schizophrenia from oral antipsychotics to a long-acting injectable antipsychotic can result in a significant drop in rates of hospitalization for psychotic episodes.
June 2014 ,FDA Approvals,New Antibiotic Tedizolid (Sivextro) Approved by FDA,Tedizolid phosphate is the second antibiotic for acute skin infections that the agency has okayed in the last 5 weeks.
June 2014 ,Medscape Medical News,Ruxolitinib Provides New Benchmarks in Polycythemia Vera,The JAK1/JAK2 inhibitor improved signs and symptoms of the disease in a phase 3 trial.
June 2014 ,Medscape Medical News,"Lithium, Quetiapine Equally Effective for Bipolar Disorder","Lithium and the second-generation antipsychotic quetiapine have similar efficacy, a real-world, head-to-head comparison shows."
June 2014 ,Medscape Medical News,Attitudes Affect Adherence to Inflammatory Disease Meds,"For a range of chronic immune-mediated inflammatory diseases, patients' beliefs and concerns can influence how well they adhere to drug therapy, new research shows."
June 2014 ,Medscape Medical News,Selumetinib Yields Modest Benefits in Rare Eye Cancer,The first randomized controlled trial of the MEK inhibitor selumetinib finds modest improvement in clinical outcomes of advanced uveal melanoma but high rates of adverse effects.
June 2014 ,Medscape Medical News,No Added Cognitive Risk to Breast-Fed Kids of Moms on AEDs,"In a new report from the NEAD study, school-aged youngsters whose mothers took antiepileptic drugs while breast-feeding scored higher on IQ test than those whose mothers didn't breast-feed them."
June 2014 ,Medscape Medical News,Thalidomide for Hemorrhagic Telangiectasia Epistaxis,"Partial or complete response is achieved with low-dose thalidomide when other therapies have failed; however, relapses are common."
June 2014 ,Reuters Health Information,Shire to Test Its ADHD Drug in 4- to 5-Year-Olds in U.S.,Shire Plc has agreed to a U.S. Food and Drug Administration request to study its stimulant Vyvanse in preschool children as concern rises over the diagnosis and treatment of attention deficit hyperactivity disorder.
June 2014 ,Medscape Medical News,BRAF Inhibitor Is Effective in Hairy Cell Leukemia,The drug could be important for the many patients who lose response or relapse with the most effective conventional therapies.
June 2014 ,Medscape Medical News,Stopping Immunotherapy Possible in Some Patients With Lupus,Some patients with systemic lupus erythematosus who are in clinical remission with immunosuppressant therapy may be able to stop therapy without triggering a new disease flare.
June 2014 ,Medscape Medical News,FDA Panel Debates CV Safety of Opioid Constipation Drugs ,An FDA advisory committee agreed that cardiovascular outcomes trials aren't necessary for an emerging class of drugs that decrease the gastrointestinal adverse effects of opioids without reducing analgesia.
June 2014 ,Medscape Medical News,Screen for Hydroxychloroquine Retinopathy to Preserve Vision,Hydroxychloroquine retinopathy can cause damage that may continue for 3 or more years after the drug is discontinued and greatly reduce the amount of visual loss.
June 2014 ,Medscape Medical News,Natalizumab Continued Past 24 Months Safely in MS,Results from the TY-STOP observational study show patients with MS safely continued natalizumab past 24 months and had less disease activity vs going to a different drug or stopping all together.
June 2014 ,Medscape Medical News,Study Finds Metformin Works Better in African Americans,"Findings from a large health system database suggest that, across several different analyses, glucose-lowering with metformin was consistently better among African Americans compared with whites."
July 2014 ,Medscape Medical News,Celecoxib May Reduce Pain After Face-lift,"The COX-2 inhibitor does not have the considerable adverse effects of opioids, but the cost is high, and insurance may not cover it. "
July 2014 ,International Approvals,Canada OKs Aptiom as Add-On Therapy in Epilepsy,Eslicarbazepine (Aptiom) is indicated as adjunctive therapy for partial-onset seizures associated with epilepsy in adults who do not respond adequately to conventional therapy.
July 2014 ,News Alerts,EU Restrictions on Bromocriptine for Inhibiting Lactation?,"The EMA committee has concluded that 'rare but potentially serious...cardiovascular, neurological, and psychiatric side effects cannot be ruled out.'"
July 2014 ,Medscape Medical News,'Mississippi Baby' Thought 'Cured' of HIV Relapses,An infant who was seemingly cured of HIV now has detectable levels of the virus after 2 years without any evidence of the virus.
July 2014 ,Medscape Medical News,Lung Societies Want Restrictions or Ban on e-Cigarettes,The Forum of International Respiratory Societies has called on governments to ban or restrict use of electronic cigarettes until their health effects are better understood.
July 2014 ,Heartwire from Medscape,Naproxen CV Safety vs Ibuprofen Challenged in WHI Analysis,"Common perceptions about the CV safety of NSAIDs took a hit in a Women's Health Initiative study, but not everyone agrees with it."
July 2014 ,Medscape Medical News,Tight Glycemic Control More 'Burden' Than Benefit for Many,"Benefits of tight glycemic control are often outweighed by treatment ""burden"" from side effects such as weight gain, hypoglycemia, or needing frequent insulin injections, according to new research."
July 2014 ,Medscape Medical News,Psychotherapy May Be Best Approach for Psychogenic Seizures,Psychotherapy that includes cognitive behavioral therapy and targets trauma and other issues may be the best treatment for patients with psychogenic seizures.
July 2014 ,Medscape Medical News,Steroid Epidural Injections No Benefit in Spinal Stenosis ,Epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit in the treatment of lumbar spinal stenosis.
July 2014 ,Medscape Medical News,"In Utero Exposure to SSRI May Up Obesity, Diabetes Risk","New animal research suggests in utero exposure to fluoxetine may increase risk for metabolic disorders, including diabetes."
July 2014 ,Reuters Health Information,Cryopreserved Testicle Tissue Used to Produce Baby Mice,Scientists have for the first time produced live offspring from testicle tissue that was cryopreserved and say a similar technique might one day be used to preserve the fertility of boys facing cancer treatment.
July 2014 ,Medscape Medical News,Largest Study to Date: Transgender Hormone Treatment Safe ,"A multicenter study of more than 1500 patients receiving cross-sex hormone therapy for at least a year showed that most side effects were minor, providing reassurance on safety."
July 2014 ,WebMD Health News,Inhaled Insulin: What to Tell Patients,"Get ready to answer patients' questions about Afrezza, a new inhaled-insulin product."