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FDA panel backs continued sales of arthritis drugs

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.

Discussion hinged on whether benefits claimed by manufacturers—notably, protection against intestinal bleeding caused by other pain relievers—justified the additional risk of heart disease.

Wood said no credible studies show Celebrex affords better gastrointestinal protection or that its pain-relief benefits exceed those of older painkillers.

If that's true, he said, there would be no need for it, since patients could get pain relief from other anti-inflammatory drugs without cardiovascular risk.

However, Dr. John T. Farrar, of the University of Pennsylvania Center for Clinical Epidemiology and Biostatics, said patients might derive benefits from some Cox-2s compared with other pain relievers, despite murky clinical trial results.

"What we are talking about here is patients who are not responsive to other drugs," Farrar said. "These agents work in a different matter. ... It is not clear to me as a pain specialist that we yet understand all the complexities of that. What we have heard from patients is that these drugs work very effectively in some patients for whom other drugs did not work."

The lone no vote on Celebrex came from the panel's only consumer representative, Arthur Levin, who voiced concern that warning labels and other techniques might not be effective in making sure that only patients who need the drug get it.

"One of the reasons for my no vote is this concern about the ability of the FDA to limit the use of the drug to an appropriate population," Levin said.

The panel members didn't vote on a proposal to place so-called "black box" warnings on the medications warning of cardiovascular risk. But each panel member was polled on the subject, and the great majority supported such a warning.


(c) 2005, Knight Ridder/Tribune Information Services.

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