FDA panel urges baby-friendly dosage instructions on acetaminophen (Tylenol) labels

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In a unanimous 21-to-0 vote, an FDA advisory panel recommended that the FDA require labels for acetaminophen-containing pain relievers to include weight-based infant dosage instructions to help prevent overdoses. Focusing exclusively on over-the-counter medications whose only active ingredient is acetaminophen, such as Children’s Tylenol and Novartis’ Triaminic, the panel also suggested that dosing instructions for all children should emphasize that weight (as opposed to age) is the best way to determine dose. Currently, the labels of liquid acetaminophen medications only suggest that, for children under the age of two, parents should “ask a doctor” for dosing instructions. In a separate vote, the panel recommended 17-to-3 that the FDA consider requiring that children’s acetaminophen tablets be sold only in one concentration to avoid parental confusion and inaccurate measurements. According to a report by the American Association of Poison Control Centers, in 2010 there were 7,500 cases of children’s acetaminophen overdoses — nearly three-percent of all acetaminophen overdoses — due to dosing errors. While acetaminophen is generally safe for children, too much of it can cause liver toxicity and even liver failure.

The panel’s opinions make sense to ACSH's Dr. Gilbert Ross. “Most parents do not call a physician to ask about infant dosage and may, instead, unintentionally give their child an excessive dose. No parent likes to see their child uncomfortable because of a fever; manufacturers should have better acetaminophen dosing instructions that can help parents relieve their children’s symptoms without putting them at risk of overdose effects.”