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U.S. panel rejects Merck's Vioxx successor

Thu Apr 12, 2007 4:47pm EDT
 
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GAITHERSBURG, Maryland (Reuters) - Merck & Co Inc.'s successor to the recalled pain reliever Vioxx should not be approved, a U.S. advisory panel ruled on Thursday.

The Food and Drug Administration's panel of outside experts voted 20-1 against recommending clearance for the drug, called Arcoxia.

The agency is not required to follow panel recommendations but usually does. Merck said it expects a final FDA decision on Arcoxia by month's end.

The company had argued Arcoxia was as safe as other pain relievers on the market and would be a valuable alternative for arthritis patients who do not respond well to current options.

Panel members, however, said they saw no reason to support another pain reliever that may damage the heart without offering a clear advantage over older drugs.

Merck pulled Vioxx from the market in 2004 after research found it raised heart attack and stroke risk. Both Vioxx and Arcoxia target the Cox-2 enzyme involved in inflammation. Arcoxia is sold in more than 60 countries.

 
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