Dosing Instruction Changes on Children’s Medicines Should Increase Safety

Last week the FDA held a joint meeting of two advisory committees to hear testimony from the Consumer Healthcare Products Association, McNeil Consumer Healthcare (manufacturer of Children’s Tylenol) and the American Academy of Pediatrics (AAP). The Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee voted this week to recommend that dosing information for children 6 months to 2 years old be added to all over-the-counter children’s medicines containing acetaminophen, a change approved by doctors as well as the drug manufacturers.

Confusion caused by the lack of instructions for children under 2 years of age and instructions which contained measurement inconsistencies probably caused many unintentional drug overdoses of children by parents and caregivers administering over-the-counter children’s medicines over the years. The Consumer Healthcare Products Association says single-ingredient pediatric liquid acetaminophen medicines are “safe and effective” and recognizes that parents and caregivers need information to dose the medicines appropriately “to make them most helpful for children.”

Dr. Daniel A.C. Frattarelli, chair of the American Academy of Pediatrics’ Committee on Drugs, said the AAP supports using weight-based dosing for children “because it is a better method” to determine the amount of medicine a child should receive. “Caregivers who understand that dosing should be based on weight rather than age are much less likely to give an incorrect dose.”

While the committee members did not make any final recommendations, they discussed ways to improve the labels, including standardizing measuring units (milliliters as opposed to “teaspoons”) for all children’s medicines and offering dosing instructions with illustrations.