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FDA Panel Rules in Favor of Painkillers |
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Officials conclude the benefits of Vioxx, Celebrex, and Bextra outweigh the risks.
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.Questions remain for Vioxx, once a blockbuster seller, which Merck pulled from the market Sept. 30, 2004. Merck suggested a positive ruling by the advisers might lead it to consider putting the drug back on the market. 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. Celebrex posed the smallest risk, but even then people don’t always understand the hazards. Studies varied in the amount of hazard for each product, and 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.
This information was taken from an article on MSNBC.com 2/18/05.
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