The Food and Drug Administration has rejected Merck & Company’s bid to win approval for a successor to Vioxx, the arthritis medication that Merck withdrew from the market more than two years ago, the company said yesterday.
The decision had been widely expected ever since a panel of F.D.A. advisers voted two weeks ago by 20 to 1 against approval of the drug, Arcoxia, because of concerns that it could cause as many as 30,000 heart attacks a year if widely used.
Like Vioxx, whose name has become almost synonymous with drug safety problems, Arcoxia is among a class of anti-inflammatory drugs called cox-2 inhibitors. Such medications were developed in the hope that they would be less likely to cause stomach bleeding than ibuprofen and naproxen.
But while they did prove to safeguard the stomach, they have been linked to heart risks. Merck withdrew Vioxx in September 2004 after research showed that it doubled the risk of heart attacks and strokes.
Despite the safety concerns in the United States, Arcoxia is on sale in 63 other countries. It brought in revenue of $265 million last year.
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