As part of an ongoing series of changes involving selective COX-2 inhibitors, FDA officials on April 7 asked that a second member of this class of nonsteroidal anti-inflammatory drugs -- valdecoxib, sold as Bextra -- be withdrawn from the U.S. market.
"Today's actions protect and advance the health of millions of Americans who rely on these drugs every day," said Steven Galson, M.D., acting director of FDA's Center for Drug Evaluation and Research, in a news release on the announcement. "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."
Officials with Pfizer, which manufactures Bextra, have agreed to suspend U.S. sales and marketing of the drug, pending further discussions with the FDA. The agency also has asked Pfizer to include stronger warning labels on another COX-2 drug it markets -- celecoxib, sold as Celebrex.
In fact, the manufacturers of all NSAIDs have received similar marching orders from FDA, advising them to add warning information to drug packaging that informs consumers about the drugs' potential to increase patients' risks for cardiovascular events and gastrointestinal bleeding.
Concerns about the cardiovascular risks associated with use of COX-2 inhibitors came to light last year, culminating in the withdrawal of rofecoxib, sold as VIOXX, in September.
In February of this year, an FDA advisory committee reviewed the COX-2 inhibitors and other NSAIDs in light of additional study data regarding the relative risks and benefits of these popular anti-arthritics. Although officials at that time did not recommend withdrawing any other COX-2 drugs from the market, they made it clear that stiffer warning language -- and a tighter hand on the reins -- were likely on the way.
Visit "COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)" from the FDA for more information on today's action and additional materials on COX-2 inhibitors and NSAIDs.
