FDA Issues Warning of Liver Injury with Acetaminophen

Washington, DCThe FDA has issued a statement 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.

The FDA appears to be doing this based on the fact that “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.” The agency also states that 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.

The FDA reports that 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.

In January 2011, the FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. 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.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. The FDA noted in its statement that it will address OTC acetaminophen products in another regulatory action, stating "Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much."