FDA Orders Acetaminophen Limits in Combination Pain Killers

The Food and Drug Administration said today it will ask combination prescription drug manufacturers to limit the content of the common pain reliever acetaminophen in their products.

The new stipulation, which also requires companies to warn consumers of "the potential risk for severe liver injury" associated with the drug, will limit acetaminophen levels to 325 milligrams per dose.

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said 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 statement said.

Acetaminophen is often combined with other pain relievers and is found in many prescription and over-the-counter medicines, including Tylenol with Codeine, Percocet and Vicodin.

"There is no immediate danger to patients who take these combination pain medications, and they should continue to take them as directed by their health care provider," added Kweder. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."

Follow Surge Desk on Twitter.