Category: “Dear Doctor” Letters
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Association of Sudden Vision Loss / NAION With Erectile Dysfunction (ED) Drugs
A "Dear Doctor" Letter Was Sent In June 2006, But Only In Canada As reported previously, the erectile dysfunction (ED) drugs Cialis (tadalafil), Levitra (vardenafil hydrochloride), and Viagra (sildenafil citrate) have been associated with…
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Sanofi-Aventis Sending “Dear Doctor” Letter About Ketek Label Changes
Bolded Warning, But Not "Black Box", For Liver Problems And Reports Of Deaths In late June 2006 Sanofi-Aventis SA announced that it had added a new bolded warning about the risks of liver failure…
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FDA Reviewing Safety Of Bayer’s Heart Surgery Drug Trasylol
Studies Link Trasylol To Kidney Problems, Heart Attacks, and Strokes In mid-February 2006 the FDA issued a Public Health Advisory informing doctors and patients that the agency was evaluating the safety of Bayer AG’s…
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FDA and Health Canada Issue Warnings For Antibiotic Tequin
Advising Diabetic Patients Not To Use Tequin Due To Concerns About Blood Sugar Disorders In mid-February 2006 the FDA and Health Canada issued separate alerts regarding the threat of rare but potentially fatal side…
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Biogen and FDA Warn of Severe Skin Reactions To Lymphoma Drug Zevalin
Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), and Erythema Multiforme (EM) In late October 2005 Biogen Idec Inc. and the FDA warned doctors about severe and sometimes fatal skin reactions that have been reported…
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Eli Lilly Sends “Dear Doctor” Letter Regarding Cymbalta and Liver Injury
FDA Warning: Cymbalta May Cause Liver Damage For Patients With Chronic Liver Disease On October 17, 2005 the FDA and Eli Lilly & Co. said in a MedWatch drug alert that the antidepressant Cymbalta…
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Trileptal May Cause Toxic Epidermal Necrolysis and Stevens Johnson Syndrome
Trileptal-induced TEN, SJS, and Hypersensitivity Reactions Reported to FDA In April 2005 the FDA and Novartis Pharmaceuticals Corp. issued a MedWatch safety alert about the risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis…
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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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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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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…