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New warnings for Bextra – Updates – not to be used—in patients allergic to sulfa-containing products

New warnings for Bextra – Updates – not to be used—in patients allergic to sulfa-containing products – Brief Article

The FDA and Pharmacia Corporation are advising health-care professionals about new warnings and information in the product labeling of Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and menstrual pain (dysmenorrhea). The labeling is being updated with new warnings following postmarketing reports of serious adverse effects, including serious allergic reactions (anaphylactoid reactions). As -these reactions can be life-threatening, people who start Bextra and experience a rash should discontinue the drug immediately. In addition, the labeling will state that the drug is contraindicated–not to be used–in patients allergic to sulfa-containing products.

Health-care professionals are encouraged to report any unexpected adverse or serious events associated with the use of Bextra directly to Pharmacia Corporation, Peapack, N.J. at 1-800-323-4204 or to the FDA MedWatch program at 1-800-FDA-1088. For more information about how to submit a report to MedWatch, go to www.fda.gov/medwatch/how.htm.

COPYRIGHT 2003 U.S. Government Printing Office

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