FDA Advisors Vote to Include Acetaminophen Dosing Instructions for Infants
The FDA’s Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee met yesterday morning to discuss adding dosing directions for infants to the labels of medication containing acetaminophen.
Currently, labels instruct parents to consult pediatricians first before dosing kids under 2 years old. The advisory committees voted in three rounds (two were unanimous) to have future labels include dosing instructions for children as young as 6 months. The dosing instructions were to be based on weight, not age, for accuracy.
As over-the-counter drug manufacturers move toward a standard acetaminophen concentration for liquid medicine, based on a mandate by the FDA, the advisory committees also voted that pills, chewables, and meltaway tablets should also have one standard acetaminophen concentration in the future.
Incorrect dosing of acetaminophen, which is commonly used to relieve symptoms of pain and fever in young children, can lead to liver poisoning. If the FDA agrees to what the committees advise, infant medicine containing acetaminophen will have clearer instructions in the future.
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