FDA considers painkiller restrictions
ADELPHI, Md. - The makers of Tylenol, Excedrin, and other medications yesterday tried to dissuade regulators from placing new restrictions on their popular painkillers, including possibly removing some of them from store shelves.
The Food and Drug Administration 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 yesterday asked its experts to consider a range of options: adding a “black box’’ warning label to the products, lowering the drug dosage in some products, 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’s Theraflu, which combine acetaminophen with other ingredients that treat cough and runny nose.
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 yesterday, 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 single-ingredient drugs or prescription-strength combination drugs like Endo Pharmaceuticals Holdings Corp.’s Percocet.