updated 4/12/2007 1:00:17 PM ET 2007-04-12T17:00:17

A painkiller proposed as a successor to Vioxx may substantially increase the risk of stroke and heart attack and is no more effective for pain relief than other drugs of the same class, a federal drug safety expert said Thursday.

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Safety studies done on the proposed drug, Arcoxia, are neither adequate nor reasonable to support its approval, Food and Drug Administration scientist Dr. David Graham told a panel of agency advisers. Graham has been a leading critic of Vioxx, also known as rofecoxib.

“What you’re talking about is a potential public health disaster,” Graham said of Arcoxia. “We could have a replay of what we had with rofecoxib.”

Merck & Co. Inc. seeks FDA approval to sell Arcoxia, also known as etoricoxib, to treat the signs and symptoms of osteoarthritis. The Whitehouse Station, N.J., company withdrew Vioxx in 2004, after it was linked to a higher risk of stroke and heart attack when compared to dummy pills.

A Merck official said the company has “comprehensively characterized the safety and efficacy profile” of Arcoxia. The prescription drug is the first of its class to seek FDA approval since Merck withdrew Vioxx.

“We at Merck believe etoricoxib represents a valuable treatment option for patients with osteoarthritis. We would like to emphasize there is more long-term safety data ... for etoricoxib that any other NSAID,” said Peter Kim, president of Merck’s research laboratories.

An estimated 21 million Americans suffer from osteoarthritis. NSAIDs, or nonsteroidal anti-inflammatory drugs, are a common treatment. Arcoxia and Vioxx are types of NSAIDs called Cox-2 inhibitors, developed to be gentler on the stomach.

FDA focusing on cardio risks
The FDA said this week that new NSAIDs that increase the risk of stroke and heart attack shouldn’t be approved if safer alternatives are available.

The FDA convened a panel of expert advisers to weigh whether to recommend the agency approve Arcoxia. The FDA isn’t required to follow the advice of its advisory committees but usually does. Merck hopes FDA will make a final decision by month’s end.

The FDA said its focus in evaluating Merck’s application for Arcoxia, and all other drugs from that class, will be specifically on its risks to the cardiovascular system. Any NSAIDs merit approval only if they fill an unmet need for a particular group of patients who have no relatively safer options available, the FDA said in a March 21 memorandum released this week. The FDA doesn’t doubt the drug works for osteoarthritis.

The only Cox-2 inhibitor still sold in the U.S. is Pfizer Inc.’s Celebrex. The New York company withdrew another of the drugs, Bextra, in 2005.

Merck said the cardiovascular risk of Arcoxia was comparable to another, older NSAID called diclofenac, based on the results of a study that enrolled nearly 35,000 patients. Arcoxia causes more high blood pressure than the older drug.

Graham and other critics believe a fairer comparison would have been to use other NSAIDs, like naproxen, sold as Aleve and under other names. They maintain diclofenac raises heart risks. Merck disputes that.

Diclofenac is widely used worldwide, but in the United States accounts for just 5 percent of the market for prescription NSAIDs.

Based on smaller and shorter studies, Merck said the cardiovascular risk of Arcoxia was consistent with that posed by other NSAIDs, but greater than that posed by naproxen. The company already sells Arcoxia in 63 other countries.

Intense scrutiny
In the U.S., the safety of Cox-2 inhibitors has drawn intense scrutiny from regulators, drug companies, academics, lawmakers, advocacy groups and the media in the wake of Vioxx’s withdrawal.

Graham has been outspoken on safety issues with the drugs. In 2004, he testified before a Senate committee that the FDA had fumbled its handling of Vioxx, and mishandled safety problems with five other widely used drugs.

If the FDA approves Arcoxia, Merck said it had no immediate plans to advertise the drug on television. Merck’s splashy ad campaign for Vioxx included TV spots that featured Olympic ice skater Dorothy Hamill.

© 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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