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Arcoxia gets thumbs down

            WASHINGTON - The U.S. Food and Drug Administration (FDA) turned down Merck & Co.'s request to market Arcoxia, a successor to its banned arthritis drug Vioxx, HealthDay News noted. An FDA advisory panel of medical experts voted 20-1 against approval on April 12. Arcoxia is a cox-2 inhibitor, the drug class that includes Vioxx, Bextra, and Celebrex. Vioxx was withdrawn in September 2004, after studies showed it doubled the risk for heart attack and stroke. Bextra was withdrawn for similar reasons early in 2005.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 drugstore shelves with a strong warning label highlighting potential heart risk. "Having a similar drug in the market is no reason to approve (Arcoxia) or any other similar drug," Dr. Robert Meyer, director of the FDA's Office of Evaluation, said after the panel's vote. He told a news conference at the time the panel wanted any new non-steroidal anti-inflammatory drugs, which include cox-2 painkillers, to undergo head-to-head comparisons to similar drugs before applying for U.S. approval. The FDA decision was preceded by a barrage of criticism over Arcoxia's potential risk for increasing heart attacks and strokes, particularly among people with existing heart disease.

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