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FDA Oks Sale Of Vioxx Despite Dangers

HeadlineFeb 21, 2005

In other news from Washington, A Food and Drug Administration advisory panel has voted to allow doctors to keep prescribing the popular painkillers Vioxx, Celebrex and Bextra even though the panel overwhelmingly agreed that the drugs significantly increase the risk of cardiovascular problems in patients. The panel proposed that the drugs be sold with an FDA “black box” warning. Vioxx is now expected to return to the market even though nearly half the FDA panel voted against it being sold. Its manufacturer Merck voluntarily withdrew the painkiller drug in the fall. The FDA panel decided whether a drug should be allowed to be sold on a straight majority vote. The vote for Vioxx was 17 to 15. For Bextra, 17 panelists vote for the drug and 13 voted to ban it. The panel nearly unanimously recommended Celebrex remaining available. Last year FDA whistleblower Dr. David Graham publicly estimated that 139,000 Americans who took Vioxx suffered serious side effects. Of these users he estimated that the drug killed between 26,000 and 55,000 people. Dr. Sidney Wolfe of Public Citizen said the FDA’s decision “defies common sense.” Public Citizen has warned that if Merck starts selling Vioxx again that the watchdog group would immediately petition the government to have it taken off the market.

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