by Aimee Keenan-Greene

Food and Drug Administrations's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee voted May 18 unanimously to recommended changing the labels of all over the counter (OTC) single-ingredient pediatric acetaminophen products.

If the FDA follows the advice as usual, revised labels would include dosing instructions for children between ages 6 months to 2 years of age, based on weight and age.

More than eight million American kids take acetaminophen, sold under the brand name Tylenol, every week, making it the nation's most popular drug for children, according to Reuters.

“The manufacturers of pediatric acetaminophen products support the FDA advisory committee’s recommendations to give parents and caregivers more accurate and detailed dosing information where it is needed – directly on the Drug Facts label,” said Scott M. Melville, president & CEO of the Consumer Healthcare Products Association (CHPA). 

The FDA says acetaminophen toxicity is a leading cause of acute liver failure, resulting in an estimated 400 deaths every year in the US. Children are also at risk of acetaminophen overdose if they are given the adult formulation or the wrong pediatric formulation, if the dose is not calculated correctly for the child's weight, or if the wrong dosing device is used.

The joint committees in Washington, DC also unanimously voted the new labeling for children 6 months to 2 years of age should include the indication for fever reduction. The committees did not support labeling the product for pain relief in children 6 months to 2 years of age.  This indication is currently included for children over 2 years of age.

CHPA member companies have recently announced voluntary plans to convert all single-ingredient liquid acetaminophen products for children to a single concentration (160 mg / 5 mL).

Products will be labeled as "children’s and infants’" products and will include flow restrictors to make it more difficult for children to accidentally ingest the product.

Syringes will accompany all infants’ products, for children age 3 years and under, and children’s products, 2 years old to under 12 years old, will come with standardized dosing devices with visible measurement markings, as well as standardizing the unit of measurement ‘mL’ on dosing charts and devices.