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FDA panel recommends against Arcoxia

Group cites presence of Vioxx-like risks

NEW YORK -- Merck & Co.'s experimental arthritis drug Arcoxia shouldn't be allowed on the US market, a Food and Drug Administration advisory panel said, citing some of the same risks that led to the withdrawal of the similar treatment Vioxx.

The committee voted 20-1 yesterday to recommend that the FDA reject Arcoxia because its benefits in reducing pain and minimizing stomach irritation don't outweigh potential damage to the heart.

Failure to win clearance for Arcoxia would dash Merck's plans to recoup some of the $2.5 billion in annual revenue lost when Vioxx was withdrawn in 2004 after being linked to heart attacks and strokes. Those dangers were cited by the FDA advisers meeting in Gaithersburg, Md., to review the new product.

"There is nothing special about this drug that would warrant giving it to patients and putting them at risk of a cardiovascular death, period," said David Felson, a member of the advisory committee and a professor of medicine at Boston University.

The FDA usually follows the recommendations of its advisers, although it isn't required to do so. The agency must make its final decision by April 27.

Arcoxia could have $1 billion in annual sales if approved in the United States, according to analysts, some of whom said they weren't expecting approval based on published data on the drug's risks.

Studies showed Arcoxia caused more blood clots than the painkiller naproxen and is more likely to cause increased blood pressure, fluid retention, and congestive heart failure than another arthritis drug, diclofenac, an FDA official, David Graham, told the advisory panel.

"What you are talking about is a potential public health disaster," said Graham, associate director of science and medicine for the FDA's office of surveillance and epidemiology.

"We continue to believe Arcoxia has the potential to become a valuable treatment option for the many patients suffering from osteoarthritis," said a Merck spokeswoman after the advisory panel's action. '