To reduce the risk of liver damage, the Food and Drug Administration is telling drug manufacturers to limit the amount of acetaminophen in certain prescription painkillers.
The directive applies to Vicodin, Percocet and other widely used painkillers that combine acetaminophen with narcotic drugs such as codeine and oxycodone. “Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States, many of which result in liver transplant or death,” an FDA official said in a news release.
Under the FDA restriction, the limit would be 325 milligrams per capsule. Current products on the market, the Associated Press reports, contain doses of up to 700 milligrams. The FDA also said it would add a “black box” warning, the agency’s strongest, to all acetaminophen prescription products.
In June, 2009, an advisory committee voted 20-17 to pull all prescription products containing acetaminophen from the market but the agency balked at going that far and instead opted for the action announced Thursday. Given how widely used the acetaminophen combination painkillers are, “We thought this was a more reasoned and reasonable action to take,” said the FDA’s deputy director for new drugs, Dr. Sandra Kweder.
FDA officials said overdoses most often occur when patients take a second, over-the-counter medication that also contains acetaminophen without realizing the danger.
However, the FDA’s latest action will not modify those over-the-counter medications, which include Tylenol and Theraflu. The agency said it still is considering limits on those products.
