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Arcoxia Not Expected to Meet FDA Approval

Merck has been under the spotlight since it's drug Vioxx was pulled from the market in 2004. It was that same year that Merck applied for FDA approval of Arcoxia, an arthritis pain drug. But the FDA rejected their application, asking for further safety studies.

Now, the results of the largest trial ever of an arthritis drug have been published. It tested Arcoxia against an older drug already on the market, Diclofenac. Dr. Steve Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, says the study doesn't prove Arcoxia is safe.

Steve Nissen: Diclofenac itself is a very risky drug, perhaps very similar to the risk of Vioxx. So finding out that Arcoxia is similar to a drug that itself is very risky, just doesn't reassure us.

Arcoxia is already approved in 62 countries and last year generated sales of $218 million. Steve Nissen says he doesn't anticipate the FDA will approve the drug for sale in the United States. Elaine Falk, 90.3.