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U.S. Department of Health and Human Services

Safety

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Bextra (valdecoxib)

Audience: Rheumatologists and other healthcare professionals

FDA and Pharmacia/Pfizer strengthened the CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS sections of the prescribing information. In postmarketing experience, rare reports of hypersensitivity reactions (i.e, anaphylatic reactions and angioedema) and skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme, have been received. These cases, some of which were serious/life threatening, have occurred in patients with and without a history of allergic type reactions to sulfonamides.

[November 2002 - Letter - Pharmacia/Pfizer]