Acetaminophen: FDA Seeks Acetaminophen Limit in Drugs

January 13, 2011 Updated: January 14, 2011

The US Food and Drug Administration (FDA) is seeking a 325-milligram acetaminophen limit in prescription drugs, hoping to curtail the risks of liver damage in users, the federal agency said in a statement on Thursday.

Additionally, the FDA is also forcing drug makers to put liver toxicity warnings on prescription combination drugs with acetaminophen.

The new restrictions will limit the amount of acetaminophen in tablets and capsules of opioids such as Tylenol with Codeine and painkillers such as Percocet and Vicodin. Over-the-counter drugs with acetaminophen won’t be subject to the regulations.

“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” Sandra Kweder with the Office of New Drugs in FDA’s Center for Drug Evaluation and Research said in a statement.

Specifically, the FDA is targeting combination drugs that risk overdose for patients who aren’t aware of the acetaminophen content.

“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,” Kweder said.

Approximately 200 million prescriptions are written every year for the combination drugs, which presently contain as much as 750 mg of acetaminophen, Reuters reported.