Category: Side Effect: Skin Reaction (Stevens Johnson Syndrome, Toxic Epidermal Necrolysis)
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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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Sleep Disorder Narcolepsy Drug Provigil Associated With Serious Skin Reactions
FDA Links Cephalon’s Provigil To Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, And Erythema Multiforme (Posted by Tom Lamb at DrugInjuryWatch.com) According to the Fall 2007 FDA Drug Safety Newsletter (Volume 1, Number 1), which was…
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Bextra Will Not Return In Canada As Safety Risks Outweigh Benefits
Health Canada Safety Panel Cites Heart Attacks, Strokes, and Severe Skin Reactions Bextra, Pfizer’s anti-inflammatory drug for arthritis patients, will not be returned to the Canadian market according to a Health Canada announcement in…
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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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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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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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Health Canada Advisory Panel Supports Return of Painkiller Vioxx to Market
Canadian Panel Votes Against Bextra Due to Increased Risk of Serious Skin Reactions On July 7, 2005, a panel of medical experts advised Health Canada officials that, in its opinion, the arthritis drug and…
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European Drug Regulators Want Increased Warnings on All COX-2 Inhibitor Drugs
Bextra: Suspension of Marketing in European Union to Continue In a June 27, 2005 press release issued by the European Medicines Agency (EMEA), the Agency’s Committee for Medicinal Products for Human Use (CHMP) said…
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Black-box Warning for Celebrex and Other NSAIDs
FDA Requires Warning Label Changes for Painkillers In June 2005 the FDA advised Pfizer, the maker of Celebrex, and several other drug manufacturers that the package insert, or warning label, for their prescription NSAID…
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Toxic Epidermal Necrolysis (TEN) is Usually Due to Adverse Drug Reaction
Patients with Toxic Epidermal Necrolysis (TEN) Often Have Fatal Outcome Toxic epidermal necrolysis (TEN) is an infrequent, yet often fatal, severe systemic and cutaneous disease that is most often the result of an adverse…