FDA Further Restricts Acetaminophen Use

The FDA is recommending health care professionals discontinue prescribing combination drug products that contain more than 325 mg of acetaminophen in each tablet or capsule, according to a new statement yesterday.

In addition, the FDA recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit, they contact the prescriber to discuss a lower dose though two-tablet options can still be available, as needed.

Note: There is no available data to suggest that taking more than 325 mg of acetaminophen per dosage unit provides additional benefits that outweigh the risk of liver injury. In addition, the limitation will help avoid acetaminophen overdose (>4000 mg within 24 hours).

Acetaminophen is a drug that relieves pain and fever and is found in both prescription and over-the-counter (OTC) products. Combination prescription products that contain acetaminophen include opioids (eg, Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). OTC products were not affected.

This recommendation follows a January 2011 request that all manufactures limit the amount of acetaminophen dosage in existing combination prescription medications and update their labels to warn of potential risk for severe liver injury.

More than half of manufacturers voluntarily complied with the FDA’s request. However, some prescription combination drug products containing more than 325 mg of acetaminophen remain on the market and the FDA intends to begin proceedings to withdraw approval of these drugs.      

Reference:

FDA. Acetaminophen prescription combination drug products with more than 325 mg: FDA statement—recommendation to discontinue prescribing and dispensing. 2014 Jan 14. Available at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm. Accessed January 15, 2014.