Editor note: On 11/19/2001, the FDA approved Bextra (valdecoxib). On April 7, 2005, following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. Pfizer was asked to withdraw Bextra from the market by the FDA. See: FDA Announces Changes For All NSAIDs; Bextra Withdrawn From Market
Dateline: November 18, 2002
Bextra Warnings / Label Changes
The U.S. Food and Drug Administration (FDA) has issued warnings and product label changes for the drug Bextra (valdecoxib). Classified as a COX-2 selective inhibitor, Bextra was approved by the FDA on November 16, 2001, and was marketed in March, 2002, with an indication for relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, as well as treatment of primary dysmennorhea.
Postmarketing Problems
From postmarketing experience, the FDA reportedly received about 20 reports of serious reactions which include the skin diseases:
- Stevens-Johnson Syndrome
- toxic epidermal necrolysis
- exfoliative dermatitis
- erythema multiforme
And hypersensitivity reactions:
Adverse Reactions
The adverse reactions are considered rare, but some patients did require hospitalization. Since the reactions can be life-threatening, it has been recommended that people who start Bextra and develop a rash should discontinue the drug immediately. Since the reported adverse reactions occurred in patients with and without a history of allergic-type reactions to sulfonamides, the FDA has stated that Bextra should not be used by patients with a known allergy to sulfa or sulfa-containing drugs.
Pharmacia and Pfizer, in full cooperation with the FDA, sent letters on November 13, 2002, to thousands of physicians in an effort to alert them to the new warnings.
For more information:
First published: 11/18/2002
