NOTE: April 7, 2005, Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the with the FDA. For more information, please read the
FDA press release.
Bextra (valdecoxib) Warning, New Side Effects
November 13, 2002 -- FDA 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 contact their doctor and discontinue the drug
immediately.
For additional information, please visit the following MedicineNet.com ares:
Portions of the above information has been provided with the kind permission of the US Food and Drug Administration (http://www.fda.gov)
Last Editorial Review: 4/7/2005
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