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FDA Panel Urges Ban on Vicodin, Percocet
Also recommends dosing limits for OTC painkillers that contain acetaminophen, like Tylenol or Excedrin, because of link to liver damage.
By Steve Reinberg
HealthDay Reporter
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TUESDAY, June 30 (HealthDay News) -- The popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, should be banned, and the maximum dose of over-the-counter painkillers with acetaminophen, like Tylenol or Excedrin, should be lowered, a U.S. Food and Drug Administration advisory panel urged Tuesday.
The panel's recommendations followed the release of an FDA report last month that found severe liver damage, and even death, can result from a lack of consumer awareness that acetaminophen -- which is easier on the stomach than such painkillers as aspirin and ibuprofen -- can cause such injury.
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The dangers from use or abuse of Vicodin and Percocet may be even more concerning, one key panelist said.
"It seems to me that problems with opiate combinations are clearly more prevalent," Dr. Lewis S. Nelson, chairman of the FDA's Drug Safety and Risk Management Advisory Committee, said during a Tuesday press conference held after the two-day meeting.
Explaining the panel's 20-17 vote to ban prescription acetaminophen/opiate drugs, Nelson said, "There are many deaths that relate to problems with prescription opiate combination acetaminophen products, whereas the number of deaths clearly related to the over-the-counter products are much more limited."
But the FDA advisers also took aim at over-the-counter (OTC) acetaminophen products. The agency's report found that many people may consume more than the recommended dose of these pain relievers in the mistaken belief that taking more will prove more effective against pain without posing health risks. Consumers may also not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, the report said.
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Copyright © 2009 ScoutNews, LLC. All rights reserved.
Last updated 7/1/2009
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SOURCES: June 30, 2009, press conference with Sandra L. Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Lewis S. Nelson, M.D., chairman, FDA Drug Safety and Risk Management Advisory Committee, and associate professor, department of emergency medicine, NYU Langone Medical Center; John H. Klippel, M.D., CEO, Arthritis Foundation; Lewis W. Teperman, M.D., director of transplant surgery, vice chairman of surgery, New York University School of Medicine, New York City; June 30, 2009, news release, Consumer Healthcare Products Association; May 28, 2009, news release, U.S. Food and Drug Administration
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