ABOUT BEXTRA

To relieve chronic pain from arthritis, menstrual cramps or other conditions, many physicians have prescribed Bextra, a non-steroidal anti-inflammatory drug (NSAID) like Vioxx and Celebrex.

Bextra is Pfizer's brand of valdecoxib, a non-steroidal anti-inflammatory drug (NSAID that was widely prescribed as a pain reliever).

In April 2005, the U.S. Food and Drug Administration (FDA) ordered a Bextra drug recall after research studies showed that the risk of a heart attack or stoke in patients taking this dangerous drug for more than 18 months. In addition, the FDA found a strong link between Bextra and Stevens-Johnson Syndrome, a dangerous and potentially fatal skin condition. This request was based on:

Lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of dangerous cardiovascular problems in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Patients currently taking Bextra should contact their physicians to consider alternative treatments.

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