Bextra (valdecoxib) - Nov 15, 2002
Audience: Rheumatologists and other healthcare professionalsFDA 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 occured in patients with and without a history of allergic type reations to sulfonamides.
[November 2002 Letter - Pharmacia/Pfizer] PDF Format
[November 2002 Talk Paper - FDA]
[October 2002 Full, Revised Label, changes highlighted - Pharmacia/Pfizer]