Pfizer has sent updated information to healthcare professionals concerning its arthritis medication valdecoxib (Bextra), a COX-2 inhibitor indicated for the relief of signs and symptoms of osteoarthritis, adult rheumatoid arthritis, and for the treatment of primary dysmenorrhea.

In postmarketing experience, rare spontaneous reports of hypersensitivity reactions (i.e., anaphylactic reactions and angioedema) and skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme, have been received for patients treated with valdecoxib. These cases, some of which have been serious/life threatening, have occurred in patients with and without a history of allergic-type reactions to sulfonamides.

According to Pfizer, this risk exists with valdecoxib primarily within the first 2 weeks of therapy and, while very rare, at a reported rate greater than other COX-2 products. Pfizer is working with regulatory authorities to update the valdecoxib product label.

Pfizer also has conducted a review of the cardiovascular profile of valdecoxib in nearly 8,000 patients and found no data suggesting an increased risk of cardiovascular thromboembolic events in people with osteoarthritis and rheumatoid arthritis treated with the medication for 6 to 52 weeks. The company will be conducting more studies to confirm the long-term cardiovascular safety profile of valdecoxib in patients who require chronic treatment for arthritis with a COX-2 specific inhibitor.