The FDA wants to limit the amount of acetaminophen in prescription painkillers


The Food and Drug Administration said Thursday that it is asking manufacturers to limit the amount of acetaminophen in prescription painkillers such as Tylenol 3, Percocet and Vycodin to a maximum of 325 milligrams per dose because of the potential for damage to the liver. Currently, some formulations of the popular drugs contain as much as 750 milligrams of acetaminophen. The FDA recommends that people consume no more than 4,000 mg. of the drug per day and agency officials say that many people inadvertently consume more than that amount because they take two different products containing the drug without realizing it. Some products, for example, use the abbreviation APAP for acetaminophen and most people do not realize they are taking it, said Dr. Sandra Kweder of the FDA’s Center for Drug Evaluation and Research. “I was a third-year medical student before I knew APA was acetaminophen,” she said at a news conference.

More than 200 million prescriptions for the combination painkillers are written in the United States each year. Recent studies have shown that about half of all cases of liver failure, perhaps about 800 per year, are due to acetaminophen overdose, said Dr. Gerald Dal Pan, director of the center’s Office of Surveillance and Epidemiology. About 30% of acetaminophen-related calls to poison control centers were for prescription drugs.

An FDA advisory panel last year recommended that the agency take action against the combination products. Kweder said the FDA will probably also take steps against over-the-counter acetaminopehn, but that is a more complicated process and will take longer. Currently, over-the-counter products are available in 500-mg. doses, as well as time-release formulations containing 650 mg. Kweder said manufacturers could reduce the dosages if they desired.


The new restrictions will be phased in over a period of three years, so they will not create a shortage of the drugs and the products will continue to be available, Kweder said. Meanwhile, consumers should feel comfortable taking products they already have on hand. But they should read labels carefully to ensure that they take no more than 4,000 mg per day, that they do not take two products containing acetaminophen simultaneously and that they do not consume alcohol while taking such products.

A list of the affected products is available here.