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Published June 30, 2009 02:52 pm - Government experts say the maximum dose listed for Tylenol and dozens of other painkillers should be reduced to help curb deadly overdoses.


FDA panel recommends smaller doses of painkillers


By Matthew Perrone
AP Business Writer

ADELPHI, Md. (AP) — Government experts say the maximum dose listed for Tylenol and dozens of other painkillers should be reduced to help curb deadly overdoses.

In a series of votes Tuesday, a Food and Drug Administration panel endorsed lowering the maximum dose of over-the-counter acetaminophen — the key ingredient in Tylenol, Excedrin and other medications. But panelists rejected a proposal to pull NyQuil, and other cold and cough medicines that combine acetaminophen with other drugs, off the market because of their role in overdosing.

Acetaminophen is one of the most widely used drugs in the U.S. Many patients find it easier on the stomach than other painkillers like ibuprofen and aspirin, which can cause ulcers.

But despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.

FDA's experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

The group was not asked to recommend an alternative maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson's Extra Strength Tylenol is 1,000 milligrams, or two tablets.

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.



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