FDA panel calls for restricting Tylenol

ADELPHI, MD. —  Government 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, the leading cause of liver failure in the U.S., which 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.

But over-the-counter cold medicines -- such as Nyquil and Theraflu -- that combine other drugs with acetaminophen can stay on the market, the panel said, rejecting a proposal to take them off store shelves.

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

In a series of votes Tuesday, the panel recommended 21 to 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. They did not specify how much it should be lowered.

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.

A majority of panelists also said the 1,000-milligram dose should only be available by prescription.

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 Assn.

The experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60% of acetaminophen-related deaths were related to prescription products.

But some on the panel opposed a sweeping withdrawal of products that are widely used to control severe, chronic pain.

“To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake,” said Dr. Robert Kerns of Yale University.

If the drugs stay on the market, they should carry a black box warning, the most serious safety label available, the panel decided.

Percocet, Vicodin and similar treatments combine acetaminophen with more powerful pain relieving narcotics, such as oxycodone.