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FDA Talk Papers are prepared by the Press Office to guide FDA
personnel in responding with consistency and accuracy to questions from the
public on subjects of current interest. Talk Papers are subject to change as
more information becomes available.
FDA, PHARMACIA UPDATE BEXTRA LABEL WITH NEW WARNINGSFDA and Pharmacia are advising health care professionals about new warnings and information in the product labeling of the drug Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). The labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions -- including Stevens Johnson Syndrome, and anaphylactoid reactions (serious allergic reactions). In addition, the labeling will state that the drug is contraindicated -- not to be used -- in patients allergic to sulfa containing products. On November 13, 2002, Pharmacia, the manufacturer of Bextra sent letters to health care professionals advising them of postmarketing reports and new warnings that will be included in the drug label. Since the firm began marketing the drug in March of 2002, cases of the serious skin and hypersensitivity reactions have been reported. These included cases of Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme. Although these adverse events are rare, some of these patients required hospitalization. Based on these reports, FDA has approved labeling changes for Bextra that include a warning for serious skin reactions. As these reactions can be life threatening, people who start Bextra and experience a rash should discontinue the drug immediately. 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. The Medwatch form is available online at http://www.fda.gov/medwatch/safety/3500.pdf for download by mail (or fax, 1800-FDA-0178) to MedWatch, HFD-410, FDA, 5600 Fishers Lane, Rockville, MD 20857. #### To read the letter sent to healthcare professionals, click HERE. |
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