Tag: FDA
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Will The FDA Follow The EMA And Order A Meridia Recall After Its September 2010 Advisory Committee Meeting
NEJM Editorial: There Should Be A Meridia Recall As The Risk Of Heart-Related Side Effects Is Greater Than Any Weight-Loss Benefit (Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: Abbott Pulls Meridia in U.S. Amid FDA Safety…
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Popular Seizure And Bipolar Disorder Medication Lamictal Associated With Aseptic Meningitis In August 2010
FDA Working With GlaxoSmithKline To Update Label, Or Package Insert, And Patient Medication Guide To Warn About This Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com)On August 12, 2010 the FDA announced that Lamictal…
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Mixed Signals About The Safety Of Acne Medication Accutane (Isotretinoin) Continue To Emerge In Summer 2010
FDA Says Accutane Was Not Withdrawn Because Unsafe Drug, While Medical Journal Article Finds Link Between Isotretinoin Therapy And Ulcerative Colitis (Posted by Tom Lamb at DrugInjuryWatch.com)When we last wrote about the acne medication Accutane…
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More Evidence That The Stop-Smoking Drug Chantix Is Linked To Agitation, Aggression, And Violence
New Medical Journal Article Looks At 78 Adverse Event Reports Made To FDA Involving Chantix / Champix (Varenicline) (Posted by Tom Lamb at DrugInjuryWatch.com) We last wrote about the relatively popular smoking cessation drug varenicline —…
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Rheumatoid Arthritis Drug Arava Gets Increased Warning For Liver Injury In July 2010
The Bolded Warning About Severe Liver Problems Which Was Added In 2003 Is Replaced By "Black-Box" Warning (Posted by Tom Lamb at DrugInjuryWatch.com) On July 13, 2010 the FDA issued a MedWatch Alert about a new increased…
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A Brief History Of Prescription Drug Recalls In The U.S., 1997-2010
FDA Will Consider Next Possible Market Withdrawl During July 13-14 Hearing About Avandia (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________________________________________________ UPDATE: Briefing Information from FDA and GSK released prior to July 13-14, 2010 Joint Advisory…
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Zithromax (Azithromycin) And Zmax Associated With Liver Failure And Pyloric Stenosis, Respectively
FDA Is Continuing To Evaluate These Emerging Drug-Safety Issues To Determine Whether Any Regulatory Action Is Needed (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-May 2010 we wrote an article "Zithromax-Induced Liver Injury Case…
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June 2010: FDA Launches Its Postmarketing Drug Safety Evaluations Web Site
New FDA Site Will Include A Summary Analysis Of Recently Reported Adverse Events And Related Medical Articles (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-June 2010 the FDA announced that it will be making…