Breaking News: FDA Asks Doctors to Limit Acetaminophen

The US Food and Drug Administration (FDA) is asking healthcare professionals to stop prescribing combination prescription pain relievers that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit, citing the risk for liver damage.

The action targets prescription analgesics that contain both acetaminophen and another ingredient, typically opioids such as codeine, oxycodone, and hydrocodone. Some of these combination products now have as much as 750 mg of acetaminophen per dose.

In a statement the FDA said, “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.”

“Further, 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,” they added.

The FDA said 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 1 acetaminophen-containing product at the same time; or combined alcohol with acetaminophen products.

The FDA said it will address over-the-counter (OTC) pain relievers and cold, sinus, and cough medicines that contain acetaminophen in a separate regulatory action. Normally, the maximum level allowed for these products is 500 mg, although a few extended-action pain relievers that are taken less frequently can go up to 650 mg.

“Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much,” the FDA warns.