FDA Asks Health Care Professionals to Reduce Acetaminophen Doses

The agency has asked prescribers not to prescribe medications containing more than 325 mg of acetaminophen per dose.

The FDA has asked health care professionals to stop prescribing and dispensing prescription painkillers that contain more than 325 milligrams of acetaminophen per tablet, due to concerns regarding potential liver damage.

In a warning released on January 14, 2014, the agency asserted that the benefits of taking combination products containing more than 325 mg of acetaminophen do not outweigh the risks for serious liver damage. With the new recommendation, the FDA also hopes to reduce the occurrence of accidental acetaminophen overdoses, which can cause liver failure and death. Severe liver injury has also occurred in patients who simultaneously took multiple products containing acetaminophen and in those who consumed alcohol while taking acetaminophen medications.

The FDA also requested that pharmacists play a role in helping to prevent liver damage caused by acetaminophen products. The warning suggests that when pharmacists receive a prescription for combination products containing more than 325 mg of acetaminophen, they should contact the prescriber and recommend a product with a smaller dose of the drug. When appropriate, a 2-tablet dose is still acceptable, for a total dose of 650 mg of acetaminophen.

In January 2011, the FDA asked drug manufacturers to limit the amount of acetaminophen in products that contain the drug to 325 mg. The FDA requested that these limitations to acetaminophen be made by January 14, 2014. More than half of manufacturers voluntarily agreed to limit the amount of acetaminophen in their products, but some prescription products containing more than the recommended amount of the drug are still available. The warning notes that the agency plans to take steps to withdraw approval of combination products that contain high amounts of acetaminophen per dose.

The warning does not apply to over-the-counter products containing acetaminophen, and notes that these products will be addressed in a future regulatory action.