SILVER SPRING, Md. — Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.
The joint committees — including both the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee — also supported a new label indication of fever for APAP for use in children between the ages of 6 months and 2 years. The committees did not support, however, an indication in labeling for children between ages 6 months to 2 years for pain relief. This indication currently is included for children older than 2 years.
"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," stated Scott Melville, president and CEO of the Consumer Healthcare Products Association.
The CHPA also had supported a new indication for acetaminophen as a pain reliever in children under the age of 2 years, noting that pediatricians today recommend acetaminophen as a mainstay for the treatment of pain, including pain associated with ear infections, sore throat, teething and minor conditions. The advisory committees, many of whom are pediatricians, suggested that physicians can continue to recommend these medicines for pain relief in infants.