Keep selling arthritis drugs, FDA panel recommends

WASHINGTON — Even though popular arthritis painkillers Vioxx, Celebrex and Bextra increase the risk of heart attack and stroke, they should be allowed to be sold to the public with strong risk warnings attached because they're effective, a Food and Drug Administration advisory panel recommended Friday.

The full FDA isn't required to go along with the panel's recommendation but is expected to give it great weight. FDA officials said the agency would act within weeks.

The panel was nearly unanimous in recommending the continued sale of Celebrex but was divided on Bextra and Vioxx, reflecting concern over studies showing both drugs were riskier.

Merck & Co. withdrew Vioxx from the market Sept. 30, citing studies pointing to cardiovascular risk, but the company said Thursday that it might begin marketing Vioxx again based on appeals from patients and new study results.

Pfizer, the manufacturer of Bextra and Celebrex, has continued to sell the medications, despite similar safety concerns.

The FDA panel's ruling was a stunning turnabout of fortune for a class of drugs that has been under a cloud for months and illustrated the panel's uncertainty about how to interpret clinical-trial results that show varying levels of risk.

Vioxx troubled panel members most.

"I think the data here are very compelling. There is a clear signal that this drug (Vioxx) appears substantially worse than the others," said Dr. Alastair Wood of the Vanderbilt University School of Medicine, who chaired the group.

The panel of medical and public-health experts voted 31-1 in favor of Celebrex, 17-13 for Bextra and 17-15 for Vioxx. Their decision came toward the end of a three-day hearing on the potential health risks of a class of painkillers known as Cox-2 inhibitors.

The drugs were developed for use by patients who are vulnerable to internal bleeding sometimes induced by an earlier generation of painkillers, such as ibuprofen.

A dominant theme throughout the hearing was the seeming uncertainty over whether various studies showing health risks were powerful enough to warrant taking the drugs off the market or whether their sales should be restricted.

Several arthritis patients and physicians testified that Cox-2 type medications were the only drugs that worked for them. The patients said they were willing to accept the risk of heart attacks in exchange for relief from arthritis pain.