FDA keeps painkillers on market
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. *



