FDA Advises Against High-Dose Acetaminophen Combinations

The Food and Drug Administration has advised physicians to discontinue prescribing medications that contain more than 325 mg per dose of acetaminophen, citing risks to the liver.

There is no good evidence for efficacy above this dose, says the Safety Alert from the Agency, and severe liver injury has occurred in patients who took more than the recommended dose over 24 hours, combined different drugs containing acetaminophen, or drank alcohol while taking the drug.

Although manufacturers of over-the-counter drugs have limited acetaminophen doses to 325 mg, some prescription combinations continue to contain larger doses. The FDA says it is considering withdrawing approval for these combinations.