FDA Sets Limit on Acetaminophen in Combo Pain Meds

Jan. 13, 2011— -- The U.S. Food and Drug Administration says makers of combination prescription medications can include no more than 325 mg of acetaminophen in each tablet or capsule.

The decision to restrict acetaminophen content was driven by the risk of liver toxicity from the products, which account for about 200 million prescriptions in the U.S. each year, the FDA said a press briefing.

To that end, manufacturers of Rx products containing acetaminophen -- usually opioids like codeine, oxycodone, and hydrocodone -- will be required to include a boxed warning on the risk of severe liver injury in product labeling.

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A 2007 CDC study estimated that about 1,600 cases of acute liver failure occur each year, although the CDC did not provide information about the cause of those cases.

But another study attributed 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths each year over a nine-year period to acetaminophen-related overdoses.

"Overdoses from prescription 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," said Dr. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in FDA's Center for Drug Evaluation and Research (CDER), on a conference call with reporters.

The FDA will also require labels to include a regular warning on the potential for allergic reactions, such as swelling of the face, mouth, and throat, difficulty breathing, itching, or rash.

The changes, which will be phased in over three years, will not affect over-the-counter medications that contain acetaminophen -- which already contain a warning about liver injury -- and is not expected to create a shortage of pain medication, said Dr. Sandra Kweder, deputy director of the Office of New Drugs in CDER, on the call.