FDA advisory panel recommends lower doses of acetaminophen

An advisory panel to the FDA is urging a ban on popular prescription painkillers Vicodin and Percocet, and has recommended lowering the maximum dose of certain other medications that contain acetaminophen.

Panel members were split on the vote, but many agreed that Vicodin and Percocet, which contain opiate narcotics as well as acetaminophen, have been linked with severe liver damage and even some deaths. Some morbidity has also been reported in pediatric patients in connection with misuse of products that contain only acetaminophen, but those reports are far less frequent than those noted with the prescription combination products, committee members said. These reports led FDA officials to recommend not using certain cold medications in children aged younger than 2 last year.

The panel’s recommendations included lowering the maximum daily dose of nonprescription acetaminophen, and lowering the 1,000-mg dose of acetaminophen to 650 mg.

“While we are pleased with the committee’s recommendation to allow continued access to over-the-counter combination medicines containing acetaminophen because we know they provide real benefits to consumers, we are disappointed in their divided vote to lower the maximum daily dose and the single dose of 1,000 mg acetaminophen,” Linda A. Suydam, president of the Consumer Healthcare Products Association (CHPA), said in a press release. “There was a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms.”

The CHPA called on the FDA to add dosing instructions on pediatric products intended for children and to increase “educational efforts to encourage appropriate use of acetaminophen.”