On 1/13/2011 U.S. Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action limited the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.

In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) were added to the label of all prescription drug products that contain acetaminophen.

These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.

Reports of Severe Liver Injury

FDA continues to receive reports of severe liver injury associated with the use of products that contain acetaminophen.

Sandra Kweder, M.D., deputy director of FDA’s Office of New Drugs, says the agency’s most recent action is aimed at making pain medications containing acetaminophen safer for patients to use.

“Overdoses from prescription products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the U.S., many of which result in liver transplant or death,” says Kweder.

A summary of data from four different surveillance systems indicates that there were an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths per year related to acetaminophen-associated overdoses during the 1990s. Within these estimates, unintentional acetaminophen overdose accounted for nearly 25 percent of the emergency department visits, 10 percent of the hospitalizations, and 25 percent of the deaths.

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