ADELPHI, Md. — Government experts called for sweeping safety restrictions Tuesday on the most widely used painkiller — acetaminophen, the active ingredient in Tylenol and other pain relievers — including reducing the maximum dose 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.
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, though it usually does.
In a series of votes Tuesday, the panel recommended 21-16 to lower the current 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 experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60 percent of acetaminophen-related deaths are related to prescription products.
Percocet and similar treatments combine acetaminophen with more powerful pain relieving narcotics, such as oxycodone.
If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.
But some on the panel opposed a sweeping withdraw of products that are widely used to control severe, chronic pain. Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to the FDA.
“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 we don’t eliminate the combination products we should at least lower the levels of acetaminophen contained in those medicines,” said Sandra Kewder, FDA’s deputy director for new drugs, summarizing the panel’s vote.
If the drugs stay on the market, they should carry a black box warning, the most serious safety label available, the panel decided.
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