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Date Submitted:
12/12/07
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FDA Says No to Vioxx Successor
Description:
The U.S. Food and Drug Administration on Friday turned down Merck & Co.'s request to market Arcoxia, a successor to its banned arthritis drug Vioxx.
The decision came as little surprise, since an FDA advisory panel of medical experts had already voted 20-1 against the drug's approval on April 12. Arcoxia (etoricoxib) is a cox-2 inhibitor, the same class of drugs that includes Vioxx, Bextra and Celebrex. Vioxx was withdrawn from the market in September 2004, after studies showed it doubled the risk for heart attack and stroke. Bextra was withdrawn for similar reasons early in 2005. Celebrex remains on drug store shelves, albeit with a strong warning label highlighting potential heart risk. But "just having a similar drug in the market is no reason to approve this drug (Arcoxia) or any other similar drug," Dr. Robert Meyer, director of the FDA's Office of Evaluation in its Center for Drug Evaluation and Research, said after the advisory panel Read the Complete Article Similar content: FDA Advisory Panel Rejects Vioxx Successor, in Arthritis Vioxx Ban Tied to Rise in Serious GI Trouble , in Arthritis Vioxx Safer on Lower Digestive Tract, Too, in Arthritis Vioxx Settlement Puts Painkillers Back in the Spotlight, in Arthritis |
