Category: Drug Safety Alerts
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Controversy Over Safety of Heart Failure Drug Natrecor Continues
Doubting Its Safety, Dr. Eric Topol and Others Want Natrecor Recalled In the October 6, 2005 issue of The New England Journal of Medicine ("NEJM") appears a letter to the editor by Jonathan Sackner-Bernstein,…
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Toprol: AstraZeneca and FDA Warn of Medication Errors Due to Similarly Named Drugs
"Dear Doctor" Letter About Reports of Patients Receiving Topamax and Tegretol Rather Than Toprol In late September 2005 the FDA and AstraZeneca warned of medication errors and pharmacy mistakes involving three brand-name medications: Toprol,…
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Cardiac Drug ReoPro: Clinical Trial Is Suspended by Lilly and J&J
Drug Companies Had Been Testing ReoPro for Treatment of Ischemic Strokes On October 5, 2005 it was reported that Eli Lilly & Co. ("Lilly") and Johnson & Johnson ("J&J") have temporarily suspended a late-stage…
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Bextra: Strong Association With Stevens-Johnson Syndrome (“SJS”) and Toxic Epidermal Necrolysis (“TEN”)
SJS and TEN are Severe Acute Life-threatening, Drug-induced Skin Disorders Linked to Bextra and Celebrex Stevens-Johnson syndrome and toxic epidermal necrolysis are closely related severe acute life-threatening, drug-induced skin disorders. The FDA Adverse Events…
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Paxil Label to Get an Increased Warning About Possible Birth Defects
Glaxo Says It Does Not Know Whether Paxil Causes Any Abnormality or Malformation in Babies A September 27, 2005 FDA MedWatch alert broadcast the news that GlaxoSmithKline Plc had sent a "Dear Doctor" letter…
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Biogen Idec and Elan Want to Resume Selling Their MS Drug Tysabri in the U.S.
Tysabri Recalled From the Market in Early 2005 Due to PML, a Fatal Brain Condition Biogen Idec Inc. and Elan Corp., the makers of the multiple sclerosis ("MS") drug Tysabri, filed papers with the…
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Pfizer Agrees to New Celebrex Safety Guidelines in Canada
Health Canada Revisions to Celebrex Label Accepted by Pfizer Canada On September 21, 2005 Pfizer Canada announced the drug company had agreed to make changes suggested by Health Canada that add new safety guidelines…
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Even One Day of Vioxx Use Can Cause Heart Attack or Stroke Says Expert
Dr. Benedict Lucchesi Testifies at Humeston Vioxx Trial in New Jersey Dr. Benedict Lucchesi, a prominent heart and medication expert from the University of Michigan, told the jury hearing evidence at the Humeston Vioxx…
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FDA Mandates “iPLEDGE” Accutane Registry in Effort to Prevent Birth Defects
Patients Must Register by December 31, 2005 to Get Accutane Re-fills In mid-August 2005 the FDA mandated that all patients who uses the acne drug Accutane will have to enroll in a national Accutane…
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Anti-Cancer Drug Herceptin Associated With Significant Risk of Cardiotoxicity
Genentech Says Its Breast Cancer Drug Can Increase Risk of Heart Problems The FDA and Genentech, Inc. have warned healthcare professionals by means of an August 2005 "Dear Doctor" letter of study data linking…