Clearer kids' dosing urged for acetaminophen-containing meds
May 18th, 2011
01:36 PM ET

Clearer kids' dosing urged for acetaminophen-containing meds

It's a stressful moment for parents: Your little baby is awake in the middle of the night, crying and screaming with a fever. You reach for the children's fever-reducer in your medicine cabinet but the side of the box says to "ask a doctor" about the appropriate dose for a child under two. But at that hour, you can't reach a doctor. How much medicine do you give your child?

To make that guessing game easier, two FDA advisory committees have voted to recommend that dosing information for children six months to two years old be added to all over-the-counter children's medicines containing acetaminophen. Members of the FDA's Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee held a joint meeting for two days to hear testimony from, among others, the American Academy of Pediatrics, the Consumer Healthcare Products Association, and McNeil Consumer Healthcare, the manufacturer of Children's Tylenol, one of the most common children's medicines that contains acetaminophen.

“Single-ingredient pediatric liquid acetaminophen medicines are safe and effective and parents and caregivers need information to dose appropriately to make them most helpful for children,” according to a presentation overview from the Consumer Healthcare Products Association.

The committees also voted in favor of using a child's weight, not just their age, to calculate an appropriate dosing regimen for all children ages two to twelve. In a prepared statement to the joint meeting, Dr. Daniel A.C. Frattarelli, chair of the American Academy of Pediatric's Committee on Drugs, said the AAP has supported the idea of using weight-based dosings for nearly 14 years because it is a better method of determining how much 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,” explains Frattarelli.

The joint meeting also addressed some of the confusing label instructions and various concentrations of acetaminophen that parents often deal with when they purchase an over-the-counter children's medicine. A recent JAMA study found that parents give their kids the wrong dose of medicine half of the time because the dosing instructions can be confusing. While the committee members did not make any final recommendations, they did discuss ideas to improve the labels, including standardizing the measuring units for all medicines from teaspoons to millilitres, and presenting additional dosing instructions with illustrations.

“By means of regulation, we can restrict how many milligrams per tablet or millilitres per ounce are allowable across all products in the OTC system, says Dr. Sandra Kweder with the FDA.

"Through regulation, we could require that... the products be packaged with dosing devices that meet certain standards,“ she says.

The committees  also voted to make all over-the-counter solid acetaminophen-containing medicines available in a single concentration, to avoid possible overdoses of the drug. For parents, that means liquid children's medicines will not have more or less acetaminophen than medicines that come in a pill form.

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