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Government considers regulating Tylenol dosage
acetaminophen: To prevent deaths, panel of experts recommends new restrictions
Published: 07/01/09  12:05 am
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ADELPHI, Md. – Experts called for sweeping safety restrictions Tuesday on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet.

The Food and Drug Administration assembled 37 experts to recommend ways to reduce deadly overdoses with acetaminophen, which is the leading cause of liver failure in the U.S. and sends 56,000 people to the emergency room annually. About 200 die each year.

“We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center.

Over-the-counter cold medicines – such as Nyquil and Theraflu – that combine other drugs with acetaminophen can stay on the market, the panel said.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

In a series of votes Tuesday, the panel recommended 21-16 to lower the maximum dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength Tylenol.

The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.

The industry group that represents Johnson & Johnson, Wyeth and other companies defended the current dosing that appears on over-the-counter products.

“I think it’s a very useful dose and one that is needed for treating chronic pain, such as people with chronic osteoarthritis,” said Linda Suydam, president of the Consumer Healthcare Products Association.

Copyright 2009 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
 

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