FDA targets acetaminophen amounts delivered in prescription painkillers

January 14, 2011

Federal health officials on Thursday announced that they were restricting the strength of Percocet, Vicodin and other popular prescription painkillers to prevent people from suffering severe liver damage from overdosing on one of the main ingredients.

The Food and Drug Administration asked drug companies to limit the amount of acetaminophen in all prescription products that combine the drug with other medications to no more than 325 milligrams per tablet or capsule.

Acetaminophen is included at much higher levels in a variety of prescription products with other ingredients, usually powerful painkillers known as opioids, such as codeine. A few examples are Tylenol with Codeine, oxycodone, which is also known as Percocet, and hydrocodone, which is sold as Vicodin.

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said the FDA's Sandra Kweder in a statement. "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."

The agency also is requiring manufacturers to update labels of all prescription products that combine acetaminophen with other substances to warn of the potential risk for "severe liver injury." All such products should start carrying "boxed warnings" - the agency's strongest warning for prescription drugs - about the potential dangers, the agency proposed.

The agency took the step at the recommendation of an advisory committee that met in June 2009 to consider the issue.

"Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products," the agency said.

The elimination of products containing higher doses of acetaminophen will be phased in over three years and "should not create a shortage of pain medication," the agency said.

The action does not affect over-the-counter products containing acetaminophen, which also reduces fever. It is widely used as an over-the-counter pain and fever medication and is combined with other over-the-counter ingredients such as cough and cold medicine.

Sidney Wolfe of the Public Citizen Health Research Group criticized the agency for failing to address over-the-counter products.

"It is inexcusably poor judgment on the part of the FDA to have failed to take action concerning this major source of acetaminophen consumption and, consequently, acetaminophen toxicity," he said.

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