Another coxib for arthritis? FDA panel says no

While physicians grapple with the risks versus benefits of available drugs for the disease, a new trial is progressing that could provide needed information.

By Susan J. Landers, AMNews staff. May 7, 2007.

Washington -- A federal advisory committee determined that the cardiovascular risks were too great and the benefits too small for the Food and Drug Administration to approve a new pain medication in the "coxib" subset of nonsteroidal anti-inflammatory drugs, or NSAIDS.

On April 12, the FDA's Arthritis Advisory Committee voted 20-1 against recommending that Arcoxia (etoricoxib) be approved by the agency to treat U.S. patients with arthritis. The drug is available in 63 other countries.

"Clearly one of the things we heard come out of their discussion was that the committee had an overall concern about the cardiovascular safety of this drug," said Robert Meyer, MD, MPH, director of the FDA's Office of Drug Evaluation II of the Center for Drug Evaluation and Research.

The worry seemed to spill over to all the coxibs and possibly NSAIDS in general, with the possible exception of naproxen, Dr. Meyer said.

This feeling is not new. Coxibs had long been under a cloud. Two of the three drugs in that group -- Vioxx (rofecoxib) and Bextra (valdecoxib) -- were withdrawn from the market in 2004 and 2005 respectively because they posed increased cardiovascular risks.

The only coxib still on the market is the prescription drug Celebrex (celecoxib), and it carries warnings of heightened heart risks.

With as many as one in five U.S. adults having been told by their physicians that they have arthritis, according to the Centers for Disease Control and Prevention, the need for effective and safe pain medication is great. Physicians are advising a range of strategies -- including physical activity, weight loss and the judicious use of NSAIDS -- to meet that need.