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FDA keeps painkillers on market

WASHINGTON - The government is letting the painkillers Darvocet, Darvon and their generic cousins stay on the market but ordered stronger warnings against deadly overdoses yesterday.

The Food and Drug Administration's decision puts the U.S. in stark contrast to Britain - which banned the drugs several years ago, citing a trail of suicides and accidental overdoses - and Europe's drug regulators, which just recommended that European Union countries do the same.

Known generically as propoxyphene, the 50-year-old prescription drug is widely used in the U.S. even though doctors consider it a weak pain reliever. The consumer watchdog group Public Citizen had petitioned the FDA to ban it here, too, saying that the small benefit didn't justify a risk that was adding up to several hundred deaths a year. In January, the FDA's scientific advisers narrowly agreed.

But the FDA overruled its advisers yesterday, at least for now. It ordered that a stern boxed warning be placed on the drug's label, and that patients soon start receiving a special pamphlet with every bottle that stresses the risk of taking too much.

Also yesterday, FDA ordered manufacturer Xanodyne Pharmaceuticals Inc., of Newport, Ky., to study the effect of higher-than-recommended doses on patients' hearts, saying that the findings could lead to additional actions. *

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