Merck's New Painkiller May Have Same Heart Risks as Vioxx Pill

[Celebration]

http://www.bloomberg.com/apps/news?pid=20601103&sid=aUiBV9yTvc6I&refer=us

Sept. 13 (Bloomberg) -- Merck & Co.'s experimental painkiller, Arcoxia, may carry the same risk of heart attacks and strokes as Vioxx, according to an analysis of 23 studies comparing side effects of several pain medicines.

The review of clinical trials published in today's Journal of the American Medical Association found that Vioxx, which Merck withdrew because of side effects in 2004, has the same level of cardiovascular risk as diclofenac, an older medication. Merck's own study published last month found that Arcoxia had a similar risk to diclofenac, which is also sold as Voltaren.

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``My conclusion is Arcoxia increases the risk of heart attack and stroke and from that perspective it is no different from Vioxx,'' David Graham, an FDA official who has been critical of the agency's handling of Vioxx, said in an interview. ``If I were part of the decision-making process I wouldn't approve it based on this study.''

In an editorial accompanying the published report, Graham criticized Merck's intentions to seek marketing clearance of Arcoxia and its study which showed the drug had no greater risk of heart attack and stroke than diclofenac.

The study's design is ``well-known to be especially poor at identifying differences in safety risks between drugs, thereby stacking the deck in favor of its drug,'' Graham wrote.