Category: FDA Drug Safety Oversight
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Improvements Needed For Reporting And Evaluating Adverse Drug Reactions In Order To Find Safety Signals
How Widespread Media Coverage, Increased Data Mining Opportunities, And Online Postings By Doctors Can Give Rise To So-Called False Positives (Posted by Tom Lamb at DrugInjuryWatch.com) The most recent headlines about Avandia are indicative…
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FDA Letter Concerning Sybmyax May Result In More Zyprexa Lawsuits For Lilly
According To Bloomberg Report, FDA Wants Information About Weight Gain And High Levels Of Blood Sugar Added To Zyprexa Label (Posted by Tom Lamb at DrugInjuryWatch.com) On June 29, 2007 Bloomberg published an article…
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FDA Explains How It Is Trying To Manage Drug Safety Issues
FDA’s Paul Seligman Answers Some Questions About The Agency’s Drug Oversight Performance (Posted by Tom Lamb at DrugInjuryWatch.com) Paul Seligman, M.D., M.P.H., is Associate Director of Safety Policy and Communication in FDA’s Center for…
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The Avandia Heart Attack Risk Was Raised To FDA Back In 2000; Will Agency Wait Until 2009 To Act?
In Comparison, Europe’s Regulators Had Glaxo Change Avandia Label In 2006 To Include Warning About Risk Of Cardiac Ischemic Events Such As Heart Attacks (Posted by Tom Lamb at DrugInjuryWatch.com) In a May 24,…
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Natrecor Safety Controversy Considered In Two May 2007 Medical Journal Articles
Is Natrecor An Example Of Why Dr. Steven Nissen Thinks That The FDA Is Dysfunctional And In Need Of Reform? (Posted by Tom Lamb at DrugInjuryWatch.com) Natrecor (nesiritide) is approved for the treatment of…
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FDA Now Provides Emerging Drug Safety Information By Means Of Audio Broadcasts, Or Podcasts
Recent Subjects Have Been Drug Recalls Involving IBS Medication Zelnorm And Parkinson’s Drug Permax (Posted by Tom Lamb at DrugInjuryWatch.com) An April 20, 2007 FDA News item reminded doctors and other health care professionals…
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Former FDA Physician David Ross Criticizes Agency’s Handling Of Ketek Case In April 2007 NEJM Article
FDA Staffers’ Letter To Editor Defends Steps Taken Over Time As Regards This Controversial Sanofi-Aventis Antibiotic (Posted by Tom Lamb at DrugInjuryWatch.com) In the April 19, 2007 New England Journal of Medicine (NEJM) appears…
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FDA Orchestrates Voluntary Recall of Parkinson’s Disease Drug Permax
Action Follows News Of Studies Which Revealed Link To Serious Heart Valve Damage (Posted by Tom Lamb at DrugInjuryWatch.com) On March 29, 2007 the FDA announced that Permax as well as two generic pergolide…
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Constipation Medication Zelnorm Linked To Apparent Increased Risk Of Heart Attacks And Strokes
Novartis Suspends Sales After FDA Determines That Risks Of Serious Side Effects Outweigh Benefits Of Zelnorm (Posted by Tom Lamb at DrugInjuryWatch.com) On March 30, 2007 the FDA announced that Novartis Pharmaceuticals Corporation had…
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March 2007 GAO Testimony On The Effectiveness Of FDA’s Postmarket Drug Safety Monitoring
FDA’s Current Initiatives May Or May Not Address Past Shortcomings — Too Early To Tell, Still (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2007 Marcia Crosse, a representative of the U.S. Government Accountability…