Safety Alerts for Human Medical Products > Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing

Safety Alerts for Human Medical Products > Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing: January 14, 2014

 FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other 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.

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