Healthcare professionals should not prescribe combination drugs that contain more than 325 mg of acetaminophen per tablet or capsule, the FDA advised on Tuesday in an effort to reduce patient risk for liver injury from accidental overdose.
Nearly half of acetaminophen-related liver failure cases in the U.S. are caused by accidental overdose from prescription combination drugs, the agency said. In particular, severe liver injury has occurred in three common scenarios, when patients:
• 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;
• drank alcohol while taking acetaminophen products.
Moreover, according to FDA data, the benefits of taking more than the recommended dose do not outweigh the added risks.
In 2011, the FDA asked manufacturers to limit acetaminophen doses to no more than 325 mg per pill by January 14, 2014, but some products are still on the market.