FDA Reminder: Limit Rx Acetaminophen Dose to 325-mg or Less

May 1, 2014 — Doctors and pharmacists should no longer prescribe or dispense prescriptions for combination-painkillers containing more than 325-mg of acetaminophen, according to a safety reminder issued by the U.S. Food and Drug Administration (FDA).

The FDA is repeating recommendations in a Safety Communication that was published on January 14, 2014. They said doctors should “consider prescribing combination drug products that contain 325 mg or less of acetaminophen.” Apparently those warnings were not sufficient.

According to the agency:

“These products were voluntarily withdrawn by the manufacturers at FDA’s request to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen.”

The action is a follow-up from January 2011, when they requested that manufacturers stop selling prescription painkillers containing more than 325-mg of acetaminophen. Manufacturers were forced to place a warning label about the risk of severe liver injury.

The FDA is now asking pharmacists not to fill prescriptions for medications containing more than 325-mg of acetaminophen. They also want wholesalers to remove product codes for the medications.

Accidental overdoses of acetaminophen are a leading cause of acute liver failure in the United States, and the trend has continued since the 1970s. Liver damage primarily occurs when patients take a combination prescription painkiller and another medication in the same 24-hour period.