FDA urges mandatory painkiller warnings

by Edmund Jenks | December 20, 2006 at 06:10 am
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FDA urges mandatory painkiller warnings

FDA urges mandatory painkiller warnings

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The Food and Drug Administration yesterday proposed mandatory labeling for over-the-counter painkillers aspirin, acetaminophen and ibuprofen.


The new warning labels would apply to drugs such as Johnson & Johnson's Tylenol, which contains acetaminophen; Wyeth's Advil, which contains ibuprofen; and Bayer, which is aspirin. The drugs are found in hundreds of other painkillers, and cold and flu medications.


More than 200 million Americans take acetaminophen alone, federal officials said.


The FDA said that although the products are safe in recommended doses, liver toxicity and stomach bleeding can occur in people with certain conditions. In a worst-case scenario, an overdose of acetaminophen can lead to acute liver failure.

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