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U.S. wants liver, stomach warnings on painkillers
2006-12-19
U.S. health officials on Tuesday proposed new warnings about liver and stomach risks on the labels of over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen. Many manufacturers already voluntarily have changed their product labels to highlight the concerns, a U.S. Food and Drug Administration statement said. Products containing acetaminophen, the active ingredient in Johnson & Johnson's Tylenol, should come in packaging that highlights the potential for liver damage, particularly when taking high doses or drinking a moderate amount of alcohol, the FDA said in its proposal. Other over-the-counter drugs called NSAIDs should carry prominent warnings about a risk of stomach bleeding in certain patients. They include people who are over age 60, are taking a blood thinner or have had prior ulcers or stomach bleeding. The NSAID warning also should say the stomach risk exists when patients ingest more than one NSAID, drink a moderate amount of alcohol or take the product for longer than directed, the FDA said. NSAIDs, or non-steroidal anti-inflammatory drugs, include aspirin, ibuprofen, naproxen and ketoprofen. The proposals were based on advisory committee discussions in 2002, scientific literature and other information, the FDA said. The agency said it would take comments for 90 days.
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