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FDA Panel Urges Tough Controls on Acetaminophen Painkillers
Date:6/30/2009

Liver harm fears could lead to ban on Vicodin, Percocet, new dosing recommendations for Tylenol

TUESDAY, June 30 (HealthDay News) -- U.S. health advisers recommended on Tuesday to lower the maximum dose of over-the-counter acetaminophen -- the key ingredient in Tylenol, Excedrin and many other pain-killing medications, while urging a ban of prescription drugs like Vicodin or Percocet, which combine the painkiller with an opiate narcotic.

The vote followed the release of a U.S. Food and Drug Administration report last month. It found that severe liver damage and even death can result from a lack of consumer awareness that acetaminophen -- which is easier on the stomach than painkillers such as aspirin and ibuprofen -- can cause such injury.

The dangers from use or abuse of Vicodin and Percocet may be even more concerning, one panelist said.

"It seems to me that problems with opiate combinations are clearly more prevalent," Dr. Lewis S. Nelson, and associate professor in the Department of Emergency Medicine, at NYU Langone Medical Center and chairman of FDA's Drug Safety and Risk Management Advisory Committee said during a Tuesday afternoon press conference held after the meeting.

Explaining the panel's 20-17 decision to ban prescription acetaminophen/opiate drugs, Nelson said that, "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
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