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FDA Near-Unanimously Rejects Arcoxia, Dubbed “Offspring of Vioxx” by Opponents


At the end of April, the FDA showed signs of coming to its senses on COX-2 inhibitors and voted 20-1 to reject Merck’s application for the painkiller Arcoxia.

Like its parent painkiller Vioxx, Arcoxia was associated with increased cardiac risks in randomized clinical trials. Public Citizen’s Dr. Sidney Wolfe, director of the Health Research Group, called not only for prohibiting Arcoxia sale in the United States, but for recall in the more than 60 countries where it is currently marketed.

Wolfe did not mince words in urging permanent rejection of COX-2 inhibitors, which were once embraced as a silver bullet for osteoarthritis patients because they are less likely to cause gastrointestinal problems.

In testimony before the FDA’s Arthritis Advisory Committee, Wolfe said, “It is time to shut the door on further additions to this dangerous class of COX-2 inhibitor drugs. The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval. In addition, further trials on these COX-2 drugs are unethical and should be stopped.”

As the proliferation of lawsuits against Vioxx make their way through the courts, surely the public will pay more attention to media exposure of the deadly risks than they did to early warnings from consumer watchdog groups. But just how many people have to die before Americans demand that all-powerful drug manufacturers stop putting profits before people?

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