Category: FDA Drug Safety Oversight
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Medtronic Sprint Fidelis Wire Leads Fracturing In Defibrillators May Have Caused Five Deaths
Events Leading Up To October 2007 FDA Recall Include A Little Noticed March 2007 "Dear Doctor" Letter And July 2007 Medical Journal Article About Model 6949 (Posted by Tom Lamb at DrugInjuryWatch.com) An October…
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How Should Drug Companies And Their Ad Agencies Respond To Safety Signals?
Two Perspectives On How Emerging Drug Safety Situations Should Be Handled Going Forward (Posted by Tom Lamb at DrugInjuryWatch.com) The September 1, 2007 edition of Pharmaceutical Executive starts with the piece "From the Editor:…
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FDA Updates Exjade Adverse Drug Reaction Numbers In Its First Drug-Safety Newsletter
FDA Post-Marketing Safety Review Adds Liver Problems To Previous Reports Of Kidney Failure Associated With Exjade (Posted by Tom Lamb at DrugInjuryWatch.com) In the first edition of FDA Drug Safety Newsletter (Volume 1, Number…
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FDA To Finally Study Possible Increased Heart Risks Caused By Attention Deficit Medications
The Safety Profile Of Adderall, Concerta, Ritalin, Dexedrine And All Other ADHD / ADD Drugs Will Be Reviewed (Posted by Tom Lamb at DrugInjuryWatch.com) In a September 17, 2007 FDA News article titled "AHRQ…
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The Use Of Antibiotic Ketek Appears To Significantly Increase Risk Of Liver Damage And Injury
2007 Medical Journal Article Reports That Ketek May Cause A Greater Than 80% Increased Risk Of Hepatotoxicity (Posted by Tom Lamb at DrugInjuryWatch.com) In early September 2007 Health Canada issued a MedEffect alert about…
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Safety Of Trasylol Will Be Reviewed By FDA Advisory Panel In September 2007
Will Consider Data Suggesting Trasylol Can Cause Kidney Damage, Heart Failure, and Death (Posted by Tom Lamb at DrugInjuryWatch.com) An August 22, 2007 article, "FDA panel will review Trasylol safety", published in the The…
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FDA / Health Canada: Long Term Use Of Nexium And Prilosec May Cause Heart Attacks Or Cardiac Death
AstraZeneca Study Information Provided To Regulatory Agencies In May 2007 Currently The Subject of Their Ongoing Safety Reviews (Posted by Tom Lamb at DrugInjuryWatch.com) On August 9, 2007 the FDA and Health Canada issued…
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Avandia Meta-Analysis By Nissen And Wolski Is Analyzed Further, And A Different Result Is Found
Risk For Heart Attack And Death From Cardiovascular Disease For Diabetic Patients Using Avandia: "Uncertain" (Posted by Tom Lamb at DrugInjuryWatch.com) On August 6, 2007 the medical journal Annals of Internal Medicine published online…
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FDA Advisory Committees To Consider Risks And Benefits, If Any, Of Avandia At July 30 Meeting
July 2007 Cochrane Review Of Trials Contends That Avandia Is No Better Than Other Diabetes Drugs While Being Associated With Serious Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On July 30, 2007 the…