The FDA elevated acetaminophen overdose concerns Tuesday, urging HCPs to avoid prescription combination medications with more than 325 mg of the analgesic.
The regulator said that there is not proven benefit to taking more than 325 mg, but that that the very same dose increases the risk of liver injury.
Tuesday’s notice comes three years after the FDA asked manufacturers to cap acetaminophen content to 325 mg per tablet or capsule by January 14 of this year.
The pain reliever is one of the most commonly used medications, both as a standalone and as a built-in component of many medications, and concern about how much patients are taking has been rising for some time: Time wrote in 2011 that Tylenol overdoses were the leading cause of liver failure in the US.
A 2009 FDA compilation of acetaminophen use showed 8 million OTC acetaminophen-only products were sold in 2005, 9.7 million acetaminophen-plus OTC products were sold in 2005, and that hydrocodone-acetaminophen prescription drugs were the most dispensed drugs between 1997 and 2005.
