FDA asks healthcare professionals to limit acetaminophen prescriptions

February 25, 2014

The U.S. Food and Drug Administration (FDA) has asked 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.

Washington, DC-The U.S. Food and Drug Administration (FDA) has asked 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.

According to the FDA, no available data shows 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 may reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

The FDA found cases of severe liver injury in patients who:

• Took more than the prescribed dose of a product containing acetaminophen in a 24-hour period

• Took more than 1 product containing acetaminophen at the same time

• Drank alcohol while taking acetaminophen products

In 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.

More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available, according to the FDA.

The FDA intends to initiate proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market. The FDA recommends that healthcare providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen.

"When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product," it adds.

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.