FDA Warns Against Rx With High Levels of Acetaminophen

Agency recommends that physicians cease prescriptions of drugs in excess of 325 mg

WEDNESDAY, Jan. 15, 2014 (HealthDay News) -- The U.S. Food and Drug Administration is recommending that physicians stop prescribing and dispensing prescription combination drug products containing more than 325 mg of acetaminophen per tablet, according to a safety alert issued by the agency.

Three years ago, the FDA requested that manufacturers of such products limit the acetaminophen amount to 325 mg or less per tablet by January 14, 2014, to protect consumers from the risk of severe liver damage. The majority of manufacturers have complied with this request, but there are still some prescription combination drugs available that exceed 325 mg of acetaminophen per tablet.

Given that there is no data to support the benefit of consuming more than 325 mg of acetaminophen per tablet over the risk of liver injury, the FDA recommends that physicians prescribe only drugs that contain 325 mg or less. When appropriate, a two-tablet dose totaling 650 mg may still be prescribed.

"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," according to the FDA safety alert.

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