Category: “Dear Doctor” Letters
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March 2009 Update: Sprint Fidelis Heart Device Connected To At Least 13 Deaths
Newly Released FDA Report Indicates Medtronic Had First Reports Of Lead Wire Problems In Late 2004 (Posted by Tom Lamb at DrugInjuryWatch.com) A March 14, 2009 New York Times (NYT) article, "Medtronic Links Device…
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New Warning About Dostinex Side Effect Fibrotic Cardiac Valvulopathy In U.K.
September 2008 Dear Doctor Letter From Pfizer Follows 2007 EMEA Safety Review Of Cabergoline (Posted by Tom Lamb at DrugInjuryWatch.com) Pfizer's Dostinex (cabergoline) remains on the market despite the January 2007 reports in the…
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August 2008: Byetta Associated With Hemorrhagic Pancreatitis And Necrotizing Pancreatitis
FDA Has Learned Of Six Such Cases Since October 2007 "Dear Doctor" Letter About Acute Pancreatitis In Patients Taking Byetta (Posted by Tom Lamb at DrugInjuryWatch.com) On August 18, 2008 the FDA issued a…
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Will There Be An Avelox – Liver Toxicity Warning Letter From Bayer Coming Soon In The U.S., Or Not?
In July 2008 FDA Said Avelox, With Other Antibiotics In Fluoroquinolone Class, Would Add A “Black-Box” Warning For Tendinitis And Tendon Ruptures (Posted by Tom Lamb at DrugInjuryWatch.com) On July 8, 2008 the FDA…
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February 2008 “Dear Doctor” Letter About Avelox / Avalox Is Sent By Bayer In Europe
Action Reportedly Intended To Emphasize 2007 Label Change About Severe, Possibly Fatal Liver And Skin Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) A February 14, 2008 Reuters article, "Bayer warns doctors on rare…
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Cholesterol Drug Zetia May Cause Serious Liver Injury Including Hepatitis And Liver Failure
Health Canada First Raised This Zetia Safety Issue In February 2005; News Reporter Discovers In December 2007 That Information Known By Merck and Schering-Plough About These Zetia Side Effects May Have Been Withheld (Posted…
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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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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…
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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…