Federal health advisers recommend Vioxx successor not be approved

WASHINGTON — A painkiller proposed as a successor to Vioxx should not be approved, a panel of federal health advisers recommended Thursday.

The nonbinding 20-1 vote was on the prescription drug Arcoxia, made by Merck & Co., Inc.

A Food and Drug Administration drug safety expert had told the panel the drug may increase substantially the risk of stroke and heart attack and is no more effective for pain relief than other medicines in the same class.

"What you're talking about is a potential public health disaster," Dr. David Graham told the outside experts before the vote. Graham was a leading critic of Vioxx, a related drug also known as rofecoxib.

"We could have a replay of what we had with rofecoxib," Graham said.

Merck is seeking the FDA's approval to sell Arcoxia, also known as etoricoxib, to treat the signs and symptoms of osteoarthritis. Merck, based in Whitehouse Station, N.J., withdrew Vioxx in 2004 after the drug was linked to a higher risk of stroke and heart attack when compared with dummy pills.

The FDA is not required to follow the recommendations of its advisory committees, but the agency usually does. Merck hopes the FDA will make a final decision by month's end.

Panel member Dr. Richard Cannon said the decision came down to whether patients needed another nonsteroidal anti-inflammatory drug, or NSAID. There are about 20 drugs in this class and they are common treatments for osteoarthritis, which affects an estimated 21 million people in the United States.

"We don't have strong data that there is a need for this drug, compared to what's already available," said Cannon, a cardiologist with the National Heart, Lung and Blood Institute.

Fellow panelist Dr. James Fries, a Stanford University rheumatologist, called it a "weak argument" that there was a "crying need" for more treatment options.

Arcoxia is the first drug of its class to go before the FDA for 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 than there is for any other NSAID, said Peter Kim, president of Merck's research laboratories.

Arcoxia and Vioxx are types of NSAIDs called Cox-2 inhibitors, developed to be gentler on the stomach.