FDA panel backs risky painkillers

Saturday, February 19, 2005

WASHINGTON -- Millions of people who depend on the popular painkillers Celebrex, Bextra and Vioxx should be allowed to keep using them despite risks of heart problems and strokes, government advisers said Friday, concluding that benefits to suffering patients outweigh the dangers.

The advisers concluded that Vioxx, which its maker Merck & Co. pulled off the market last fall, poses the greatest risk and that Celebrex has the fewest side effects.

They suggested that the prescription products carry strong warnings and recommended a long-term study to gain more understanding about the drugs.

While the Food and Drug Administration isn't required to follow the recommendations of the its advisory groups, it generally does.

Celebrex and Bextra, made by Pfizer Inc., are widely sold and are likely to remain so following the recommendations.

Questions remain for Vioxx, once a blockbuster seller, which Merck yanked from the market Sept. 30.

Merck suggested Thursday that a positive ruling by the advisers might lead it to consider putting the drug back on sale. But the vote recommending that it be made available to consumers was close, 17-15.

Since it was removed from the market voluntarily, it remains an approved drug. Merck issued a statement following the vote saying only that it was looking forward to talks with the FDA.

The panel voted 31-1 to keep Celebrex on sale and 17-13 with two abstaining for Bextra.

Meeting chairman Alistair J. J. Wood of Vanderbilt University Medical School said, "The data are very compelling, Vioxx is substantially worse than the others."

But they all contain hazards, the panelists observed.

Celebrex posed the smallest risk, but even then people don't always understand the hazards, Wood noted.

Studies varied in the amount of hazard for each product, and Wood indicated there was about a 1 percent increase in risk of heart problems from Celebrex, a seemingly small number that can translate into a lot of problems over the entire population.

But the problems didn't occur at the normal dose of 200 milligrams, the panel was told. Only when people began taking 400 milligram doses in a colon polyp study did troubles show up.

The group was unanimous in saying the drugs, known as Cox-2 inhibitors, pose risks of heart trouble. They were critical of the limited data available for Bextra.

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