08222017Headline:

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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

FDA Committee Says No to Merck's Vioxx Successor

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Merck is seeking FDA approval for a new Cox-2 inhibitor, etoricoxib (Arcoxia). However, according to the FDA’s Arthritis Drugs Advisory Committee, the drug’s cardiovascular risk outweighed its benefits. One member of the committee also indicated that it was unclear that there was the need for another product in this class of drugs. Though it is not required to, the FDA usually follows the recommendation of its advisory committees. Arcoxia is meant to ease arthritis pain, much like Vioxx, which is the Merck drug that was withdrawn from the market in 2004 due to a link to increased cardiovascular risk. Soon after the withdrawal of Vioxx, Pfizer withdrew Bextra because of similar concerns. After those withdrawals, the FDA required all non-steroidal anti-inflammatory drugs (NSAIDs), except aspirin, to have boxed warnings about cardiovascular risks on their labels. Since then, Arcoxia is the first Cox-2 inhibitor to come before the FDA for approval. Arcoxia is already approved to treat arthritis pain in 48 other countries.