F.D.A. Announces Strong Warnings for Painkillers

WASHINGTON, April 7 - Federal drug regulators issued sweeping warnings Thursday that many popular painkillers could hurt the heart, stomach or skin, and they persuaded Pfizer to withdraw its pain pill Bextra, once a strong seller.

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Tough warnings about heart risks will soon dominate the labels for prescription painkillers like Celebrex, Mobic, Naprosyn, Voltaren and more than a dozen other similar drugs, the Food and Drug Administration announced. Even the labels of popular over-the-counter pills like Advil and Aleve will have to cite risks to heart, stomach and skin, the agency said.

Few studies have examined the long-term health effects of most of these medicines, so regulators are groping a bit in the dark. Studies done on Bextra and Celebrex, both from Pfizer, and Vioxx, made by Merck, strongly suggest that they increase the risks of heart attacks and strokes. With those studies in hand and suggestions that older pills may act similarly, F.D.A. officials said that they could not rule out the possibility that all of the drugs in the class known as nonsteroidal anti-inflammatories cause similar problems. Several doctors interviewed said they would now weigh the risks and benefits case by case. [Page C4.]

"We think these risks apply to all of these drugs," said Dr. Steven Galson, acting director of the F.D.A.'s center for drugs. "There may be some differences, but our conclusion is that we don't have enough data to rank-order these risks."

Still, Dr. Galson emphasized that popular over-the-counter pain pills were safe if taken briefly and in low doses, and patients should not suddenly stop taking these medicines because of the F.D.A.'s announcement. Several experts said that naproxen, the medicine found in Naprosyn and Aleve, is probably the safest among the nonsteroidal pain pills.

Neither acetaminophen, sold as Tylenol and other names, nor aspirin are affected by the new warnings, although those medicines are not problem-free. In high doses, aspirin can hurt the stomach and Tylenol can damage the liver. Aspirin, though, protects the heart.

The latest warnings will complicate prescribing decisions for arthritis patients and others in chronic pain. There are hints in the research that the pain pills that are easiest on the stomach may be toughest on the heart, and vice versa. Aspirin, for instance, protects the heart but can irritate the stomach. Naproxen may be mildly protective to the heart but seems especially harsh on the stomach. Vioxx proved easiest on the stomach but probably has the most toxic effects on the heart. All, in rare cases, cause skin reactions.

Doctors must now ask about a patient's heart and stomach risks. Those with cardiovascular problems could get one kind of pill, and those with a history of ulcers may get another. And some drugs have uniquely beneficial effects in some patients, who may prefer to accept a measure of risk to continue taking their favored drug. The difficulties may be particularly acute for the elderly, who are often at risk for stomach and heart problems.   Continued...