Arthritis drug Bextra pulled from market; FDA warns of fatal skin reactions

The agency requested additional labeling information on nonprescription NSAIDs to warn of cardiovascular and gastrointestinal risks.

By Susan J. Landers, AMNews staff. April 25, 2005.

Washington -- The Food and Drug Administration concluded that the risks outweigh the benefits for the painkiller Bextra (valdecoxib) and asked that its manufacturer, Pfizer, voluntarily withdraw the drug from the market.

Pfizer, while disagreeing with the FDA's conclusion, announced April 7 that it would suspend sales pending further discussions with the agency.

Patients were advised to stop taking Bextra and to contact their physicians about alternatives.

In a news release, the manufacturer also said it would explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients.

Adding to the cardiovascular risks carried by Bextra, and shared with the COX-2 inhibitor Vioxx (rofecoxib), which was withdrawn from the market by Merck & Co. last fall, are risks for serious and potentially life-threatening skin reactions, according to the FDA announcement.

The agency concluded that Bextra lacked any demonstrated advantage over other nonsteroidal anti-inflammatory drugs still on the market.

"FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks," said Steven K. Galson, MD, acting director of the FDA's Center for Drug Evaluation and Research, in a statement.