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FDA Announces In November 2007 That It Will Investigate Possible Link Between Maxipime And Increased Risk Of Death
A Medical Journal Article Published In May 2007 Suggested This Emerging Drug Safety Issue; Why Was There A Six-Month Delay In Starting This FDA Investigation? (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-November 2007…
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Will New Black Box Warning About Heart Attacks Lead GlaxoSmithKline To Withdraw Avandia From Market?
One Wonders Whether GSK Might Do A "Soft" Recall Of Its Embattled Diabetes Drug, As Was Done By BMS With Serzone And Tequin In Recent Years (Posted by Tom Lamb at DrugInjuryWatch.com) Avandia (rosiglitazone)…
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Trasylol Sales In U.S. And Canada Suspended Temporarily By Bayer In Early November 2007
Market Withdrawal Or Recall Of Trasylol Seems Possible As Bayer Waits For Final Data From Halted BART Study (Posted by Tom Lamb at DrugInjuryWatch.com) On November 5, 2007 the FDA announced and Health Canada…
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New Information From FDA On Alleged Problems With Ketek Safety Study 3014
October 2007 FDA Letter Says Aventis Did Not Follow Regulations And Statutory Requirements; Company Contends Study Conducted In Good Faith (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA posted on…
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Is This What Medtronic’s March 21, 2007 “Dear Doctor” Letter Said About Sprint Fidelis Lead Problems?
One Person Took The Impression That Medtronic Was Trying To Lay Blame For Lead Wire Failures On Those Physicians Who Were Doing The Defibrillator Implants (Posted by Tom Lamb at DrugInjuryWatch.com) To start, our…
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Cephalon Added Warning To Provigil Label About Serious Skin Reactions In August 2007
A "Dear Doctor" Letter About Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated With Provigil Was Sent In September 2007 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA sent an email…