ADELPHI, Md. – (AP) – The makers of Tylenol, Excedrin and other medications are trying 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 has assembled more than 35 experts 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 U.S., sending 56,000 people to the emergency room annually, according to the FDA.
The agency today 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’ 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 today, saying they pose a relatively small risk to patients. (Read more.)
