FDA may soon revise the labeling of over-the-counter pediatric medications to place a stronger emphasis on weight rather than age for dosing instructions. In mid-May, two advisory committees to the agency, the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee, recommended a change for children’s OTC medicines that contain acetaminophen, such as Tylenol. The labeling issue has been a concern for many years now, and has gained attention since January 2008, when postmarket adverse events were reported for McNeil Consumer Healthcare’s pediatric formulations of Tylenol, Motrin, Zyrtec, and Benadryl.
The weight of children, and all individuals for that matter, varies within certain age ranges. Drugs are formulated based on age and weight, so it makes sense that dosing instructions address both. A major concern regarding dosing labels for children, in particular, is that if a child falls into a certain age range but weighs less than average for that age range, then that child could be overdosed when given a dose based on age alone.
According to the FDA briefing materials, “It has been reported that seventy percent of emergency department visits, across all age groups, related to single ingredient acetaminophen were due to unintentional overdose and two-thirds of those overdoses occurred in children less than 12 years of age.” In addition to unclear labels and labeling, causes of overdosing include: “general knowledge deficits, varying dosing devices, varying formulations and concentrations… and inadequate provision of dosing instructions to patients by their providers.”
Currently, the under-age-2 labels for OTC medications containing acetaminophen say, “Consult a doctor.” Labeling instructions for children under 6 months of age may retain the “Consult a doctor” statement, but weights and ages should be provided for children 6 months to 24 months, according to the committee recommendations.
The official minutes of the joint advisory committee meeting should be published in the Federal Register in the coming days and will contain additional details. Briefing materials used for the meeting were provided by officials within FDA, the Consumer Healthcare Products Association, and McNeil Consumer Healthcare; they are available online. The committees reviewed available pharmacokinetic, efficacy, and safety information as well.
FDA is not required to accept the committees’ recommendations but typically does.