FDA recommends high-dose acetaminophen combo drugs be discontinued

The US Food and Drug Administration is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325mg of acetaminophen per tablet, capsule, or other dosage unit.

There are no available data to show that taking more than 325mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury, the FDA said. Furthermore, 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.

In January 2011, the FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount if acetaminophen to no more than 325mg in each tablet or capsule by January 14, 2014. The agency requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.