USA. Pharmacia and Pfizer have updated the Warnings section in the product label for valdecoxib tablets (Bextra) to include hypersensitivity reactions (ana-phylactic reactions and angioedema) and skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiform as possible adverse reactions with the product. The Contraindications section advises that valdecoxib (Bextra) should not be given to patients who have demonstrated allergic-type reactions to sulfonamides. These updates are based on post-marketing surveillance reports of such reactions occurring with valdecoxib (Bextra) in patients with or without a history of allergic-type reactions to sulfonamides. In the US, valdecoxib (Bextra) is indicated for the relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis, and for the treatment of primary dysmenorrhoea.
Reports in WHO file: Face oedema 1, oedema peripheral 1
‘Dear Healthcare Professional’ letter from Pharmacia Corporation and Pfizer Inc, 13 Nov 2002. Available from URL: http://www.fda.gov