Guest guest Posted July 6, 2006 Report Share Posted July 6, 2006 SSRI-Research@ Thu, 06 Jul 2006 01:15:34 -0000 [sSRI-Research] Tylenol Linked to Liver Woes ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability www.ahrp.org FYI Overreliance on toxic drugs is killing healthy people. And the FDA has done next to nothing to prevent drug-induced harm. The Associated Press reports that high doses of Tylenol (acetaminiphen) the most popular over the counter painkiller caused abnormal liver test results in healthy adults within two weeks " raising concerns that even recommended amounts of the popular painkiller might lead to liver damage. " In a controlled study published in the Journal of the American Medical Association, the people who took placebos experienced no alarming liver test results. " But nearly 40 percent of people in all the other groups had abnormal test results that would signal liver damage " Furthermore, in clinical practice, " Overdoses of acetaminophen are the leading cause of acute liver failure. " One of our own knowledgable experts commented as follows: " We learned in our pharmacology classes 30 years ago that acetaminophen caused liver damage and that people who took a bottle in a " cry for help " , unlike those taking aspirin, would die from liver failure. FDA has done little, and now everyone acts as though this is a big surprise. " (the informer prefers to remain anonymous only to protect employment). Contact: Vera Hassner Sharav 212-595-8974 veracare THE NEW YORK TIMES July 4, 2006 High Tylenol Doses Linked to Liver Woes By THE ASSOCIATED PRESS CHICAGO (AP) -- Healthy adults taking maximum doses of Tylenol for two weeks had abnormal liver test results in a small study, researchers found, raising concerns that even recommended amounts of the popular painkiller might lead to liver damage. In the study, 106 participants took four grams of Tylenol -- equivalent to eight extra-strength Tylenol tablets -- each day for two weeks. Some took Tylenol alone and some took it with an opioid painkiller. Dummy pills were given to 39 others. There were no alarming liver test results among the people who took the placebos. But nearly 40 percent of people in all the other groups had abnormal test results that would signal liver damage, according to the study that appears in Wednesday's Journal of the American Medical Association ''I would urge the public not to exceed four grams a day. This is a drug that has a rather narrow safety window,'' said a study co-author, Dr. Neil Kaplowitz of the University of Southern California Heavy drinkers should take no more than two grams daily, Kaplowitz said. Another co-author, Dr. Paul Watkins of the University of North Carolina said he's less worried than Kaplowitz, noting that acetaminophen, the active ingredient in Tylenol, has been used for 50 years and has a good safety record. The maker of Tylenol, McNeil Consumer & Specialty Pharmaceuticals , said its own research found much lower rates of abnormal liver results. The company's studies tracked high-dose users over longer periods than did the new study. ''It doesn't lead to liver disease and it usually resolves as patients continue to take acetaminophen,'' said Dr. Edwin Kuffner, senior director of medical affairs at McNeil. The researchers had been hired by the drug company Purdue Pharma LP, maker of the prescription painkiller OxyContin, to find out why abnormal liver tests were showing up in people testing a combination drug containing the acetaminophen and the opiate hydrocodone. Purdue Pharma stopped its hydrocodone study early because of the abnormal liver tests. Researchers Watkins and Kaplowitz thought they would find the culprit in hydrocodone's interaction with acetaminophen. ''Our jaws dropped when we got the data,'' Watkins said. ''It doesn't have anything to do with the opiate. It's good ol', garden-variety acetaminophen.'' Acetaminophen is more popular than aspirin or ibuprofen. Each week, one in five U.S. adults uses it for pain or fever, a 2002 survey found. Acetaminophen is included in numerous over-the-counter and prescription medications, making overdose possible as people unwittingly combine drugs. Overdoses of acetaminophen are the leading cause of acute liver failure. ''A week doesn't go by when I don't have to talk to someone about how much they're taking,'' said Kathleen Besinque of the USC School of Pharmacy. Watkins said people considering switching painkillers should know that others have their own side effects, such as internal bleeding and stomach irritation. New research under way at the University of North Carolina may determine if acetaminophen's effect on the liver continues for long-term, high-dose users, or if the body adapts, Watkins said. ------ On the Net: JAMA: http://jama.ama-assn.org <http://jama.ama-assn.org/> Copyright 2006 The Associated Press <http://www.ap.org/> FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit. Quote Link to comment Share on other sites More sharing options...
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