WASHINGTON – The popular painkillers Celebrex (search) and Bextra are likely to stay on the market, and Vioxx (search) may rejoin them, now that government advisers have concluded their benefits outweigh their risks.
The advisers said Friday that people who depend on these drugs should be allowed to keep using them despite risks of heart problems and strokes. They suggested the prescription products carry strong warnings and recommended a long-term study.
While the Food and Drug Administration (search) isn't required to follow the recommendations of the its advisory groups, it generally does.
Celebrex and Bextra, made by Pfizer Inc. (PFE), are widely sold and are likely to remain so following the recommendations. The panel voted 31-1 to keep Celebrex on sale and 17-13 with two abstaining for Bextra.
Merck & Co.(MRK), which pulled Vioxx off the market Sept. 30, 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 Vioxx 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.
Meeting Chairman Alistair J.J. Wood of Vanderbilt University Medical School said, "The data are very compelling, Vioxx is substantially worse than the others."
Studies varied in the amount of hazard for each product. 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 changes to the way the drugs are sold, such as placing a "black box" warning on them to alert consumers to potential risks; including more patient information with the drugs; restricting which patients could get them; and possibly banning direct-to-consumer advertising.
Wood said the public must better understand the nature of risk, noting that "people worry about crime and then drive drunk."
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 noted that other painkillers also have side effects, often leading to stomach problems and bleeding.
"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.