FDA Recommends Discontinuation of Prescription Drug Products with More Than 325 mg of Acetaminophen

January 17, 2014

FDA is recommending health care professionals discontinue prescribing prescription combination products that contain more than 325 milligrams (mg) of acetaminophen per dosage unit.

There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

 Cases of severe liver injury with acetaminophen have occurred in patients who:

  • took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
  • took more than one acetaminophen-containing product at the same time; or
  • drank alcohol while taking acetaminophen products.

In January 2011, the FDA asked manufacturers of these drug products to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available.

In the near future, the FDA intends to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.

For more information, please contact the Division of Drug Information at 888-INFO-FDA (888-463-6332) or druginfo@fda.hhs.gov.

Health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

January 14 — FDA safety alert

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