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 — Posted 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Adding to the cardiovascular risks carried by Bextra, and shared with the COX-2 inhibitor Vioxx (rofecoxib), which was withdrawn from the market by Merck & Co. last fall, are risks for serious and potentially life-threatening skin reactions, according to the FDA announcement.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.
The FDA's action leaves only Celebrex (celecoxib) as the remaining COX-2 selective NSAID still available. The agency did, however, ask Pfizer, which also manufactures Celebrex, to revise that drug's label to include a black-box warning and provide a medication guide for patients with every prescription filled.
Manufacturers of other prescription NSAIDs also are being required to carry the strong heightened warning, which will highlight the potential for increased risk of cardiovascular events that accompanies the use of the drug as well as the serious and potentially life-threatening gastrointestinal bleeding associated with its use.
In addition, the FDA asked manufacturers of nonprescription NSAIDs, such as ibuprofen and naproxen, to revise their labels to include more specific information about the potential gastrointestinal and cardiovascular risks that those drugs pose.
The agency announcement was posted online on MedWatch, the FDA's safety information and adverse reporting program, The announcement specifically excluded aspirin from the warning, noting that aspirin has "clearly been shown to reduce the risk of serious adverse CV events in certain patient populations."
The FDA's decision goes beyond the recommendations made by its advisory committee after it met for three days in February. At that time, the panel voted to allow Celebrex and Bextra to remain on the market and opened the door to the possible return of Vioxx. But the panel also noted that there was little safety data on the majority of the 20 nonselective NSAIDs now sold in the United States and had favored heightened warning labels on those drugs.