FDA weighs options to curb Tylenol-related overdoses

ADELPHI, Md. — The makers of Tylenol, Excedrin and other medications Monday tried to dissuade regulators from placing new restrictions on their popular painkillers, including possibly removing some from store shelves.

The Food and Drug Administration (FDA) assembled more than 35 experts for a two-day meeting to discuss ways to prevent overdose with acetaminophen — the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.

Despite years of educational campaigns and other federal actions, acetaminophen is the leading cause of liver failure in the United States, sending 56,000 people to the emergency room annually, according to the FDA.

The agency Monday asked its experts to consider a range of options: adding a "black box" warning label to the products, lowering the drug dosage in some, or pulling certain types of medications off the market.

The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which combine acetaminophen with other ingredients that treat coughs and runny noses. The FDA says patients often pair them with a pure acetaminophen medication, 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 Pharmaceuticals Holdings' Percocet, which combines oxycodone and acetaminophen.

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

The FDA is not required to follow the advice of its panels, though it usually does. The panel vote is scheduled for this afternoon.

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.

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