FDA panelrules in favorof painkillers

In a much anticipated decision, a Food and Drug Administration panel voted Friday to allow sales of the popular painkillers Vioxx, Celebrex and Bextra, despite acknowledging the risks they pose for heart problems.

The panelists concluded the drugs' benefits outweigh the possible risks to consumers and that the medications should be available to those who need them. They suggested a number of possible restrictions for the drugs, including placing a “black box” warning on the label warning of the potential dangers and who’s at risk, providing more patient information, restricting which patients could get them and banning direct-to-consumer advertising for the products.

The advisers said 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 recommended a long-term study to gain more understanding about the drugs.

While the FDA 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 over Vioxx' future
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.

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Understanding the risks
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.

Merck shares soared after the announcement and closed up $3.76, or 13 percent, at $32.61 on the New York Stock Exchange. Pfizer shares rose $1.74, or 7 percent, to $26.80, also on the NYSE.

The advisers suggested a range of restrictions on the drugs. Some suggested giving Vioxx only to children, while other proposed requiring patients to sign an informed consent form.

But one panelist said that on a given day, some patients might be in enough pain they would sign anything.

Wood said the public must better understand the nature of risk, noting that “people worry about crime and then drive drunk.”

Long-term studies needed
Dr. Steven Nissen, medical director of the Cleveland Clinic’s heart center, said, “What we really want is to make sure it’s available for patients that need it and is unavailable to patients for whom it’s inappropriate.”

The advisers were asked to assess the drugs after Vioxx was withdrawn and questions were raised about the other Cox-2 inhibitors.

They noted that other painkillers also have side effects, often leading to stomach problems and bleeding, with some panelists saying long-term studies would be valuable for many painkillers, including ibuprofen, naproxen and diclofenac.

“There is a very important need for more information on many of these drugs,” including their effects on blood pressure, Dr. Robert Temple, director of medical policy for the FDA’s Center for Drug Evaluation and Research, told the advisers Friday.