Postmarketing reports of adverse events have led the Pharmacia Corp. to issue a warning letter to health care professionals, alerting them to changes in the product labeling for valdecoxib tablets (Bextra).
Valdecoxib is indicated for the treatment of dysmenorrhea and relief of symptoms of osteoarthritis and rheumatoid arthritis.
The labeling changes for Bextra include a warning regarding the risk of serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and erythema multi-forme. There also have been some reports of hypersensitivity reactions, such as anaphylaxis and angioedema.
These adverse events were rare, but some of the cases reported were serious and life threatening and resulted in hospitalizations. The reactions also occurred in patients with and without a history of allergic-type reactions to sulfonamides, according to the letter to health care professionals.
The Contraindications and Warnings sections of the label have been revised; the postmarketing experience is detailed in the Adverse Reactions section.
"Bextra should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity," the manufacturer advised in the letter.
Copies of the letter can be viewed at the Food and Drug Administration's MedWatch Web site, www.fda.gov/medwatch/safety/2002/bextra.htm.
Any unexpected adverse or serious events associated with the use of Bextra can be reported to Pharmacia at 800-323-4204 or to the FDA MedWatch program at 800-FDA-1088.
COPYRIGHT 2003 International Medical News Group
COPYRIGHT 2003 Gale Group
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