FDA pans Merck's new pain pill

April 13, 2007

The U.S. Food and Drug Administration has rejected Merck's bid to sell the pain medication Arcoxia in the United States.

The New York Times says Arcoxia is a sister to Vioxx, which Merck pulled from the market in 2004 after a study showed it increased the risks of heart attacks and strokes.

Arcoxia, currently sold in 63 countries, caused nearly three times as many heart attacks, strokes and deaths as naproxen, which is sold as Aleve, and is about just as effective at reducing pain in arthritis patients. Patients taking Arcoxia also suffered increased blood pressure, the newspaper said.

"What you're talking about is a potential public health disaster," Dr. David Graham, an FDA safety officer, told the panel.

The company said it was "disappointed" in the FDA's rejection.

"We continue to believe that Arcoxia has the potential to become a valuable treatment option for many Americans suffering from osteoarthritis," Merck Research Laboratories President Peter Kim said in a release.

Merck will continue to sell the drug outside the United States, the newspaper said.

Copyright 2007 by United Press International

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