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FDA Panel: Maximum Dose for Tylenol, Pain Relievers Should be Reduced to Curb Deadly Overdoses

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.

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 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.

However, some experts complained the measure would create unnecessary work for doctors and patients.

"I think the drain on the health care system, which is already strained, would be enormous," said Dr. Robert Kerns of Yale University.

The FDA is not required to follow the group's advice, though it usually does.

Panelists are scheduled to vote later Tuesday on other safety restrictions for the drugs — including possibly pulling some products off the market.

The drugs that could be withdrawn are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

But the industry group that represents Johnson & Johnson, Wyeth and other companies defended the products Monday, saying they pose a relatively small risk to patients.

Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.

The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceutical's Percocet, which combines oxycodone and acetaminophen.

Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products, according to IMS Health, a health care analysis firm.

"We believe there is a clear health benefit of over-the-counter combination products containing acetaminophen," Linda Suydam, the group's president, said Monday.