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Panel: better acetaminophen labeling needed
WASHINGTON (CNN) -- A federal advisory committee is recommending stronger warning labels on products containing acetaminophen, one of the most popular over-the-counter painkillers, because of growing reports of liver damage. The Food and Drug Administration's nonprescription drug advisory committee issued recommendations to the FDA Thursday suggesting labeling changes that would highlight all active ingredients and warn consumers not to exceed the recommended daily dose because liver damage may occur. The label would also instruct users not to take multiple products containing acetaminophen without consulting their physician. The committee is also recommending additional public service advertising campaigns that would educate consumers about how to use acetaminophen and other over-the-counter drugs safely. According to Dr. John Jenkins, director of the FDA's Office of New Drugs, the labeling changes and educational efforts are necessary to help consumers better understand the medicine and its active ingredients. Accidental overdoses of acetaminophen -- used in Tylenol and similar products --is thought to cause about 100 deaths a year in the United States. While federal health officials say acetaminophen is safe when used appropriately, the debate centered on whether additional warnings on the risks of liver damage are necessary and if more consumer education is needed because patients are unknowingly using two or more products containing the drug, thereby increasing their intake. Current warnings on Tylenol packages advise: "If you consume three or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage." It also warns, "Do not use with any other product containing acetaminophen." Taken by tens of millions of Americans each year, acetaminophen is one of the most common overdose agents reported to the American Association of Poison Control Centers. The issue of liver toxicity in association with acetaminophen use is not new. The nonprescription drug advisory committee began discussing the problem in 1977. Friday, the committee will discuss safety issues related to the use of aspirin and ibuprofen. The discussion will focus on potential gastrointestinal bleeding and kidney failure.
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