FDA to debate pediatric APAP dosing during mid-week advisory committee meeting

WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

“[The Consumer Healthcare Products Association] supports inclusion of dosing information for children less than 2 years of age on labels of [over-the-counter] single-ingredient acetaminophen products intended for children, and the amendment of the OTC Internal Analgesics Monograph to reflect this labeling,” the association stated as part of a “Briefing Book” submitted for the meeting. “Further, our members also support dosing based on weight as the preferred method for dosing children.”

The Consumer Healthcare Products Association earlier this month announced that the industry would voluntarily homogenize liquid APAP concentrations for children in an effort to reduce medication errors. Beginning mid-2011 and continuing through early 2012, CHPA members will discontinue manufacturing concentrated infant drops and convert these products to the same concentration used today for children’s (ages 2 to 11 years) acetaminophen products (160mg/5mL), the CHPA noted in its pre-meeting minutes. The industry initiative is consistent with guidance from three advisory committees to FDA in 2009 that voted 36-1 in favor of standardizing acetaminophen liquid products to one concentration. In addition, the new products will be packaged with flow restrictors to make it difficult to ingest large amounts of liquid in the event of an accidental unsupervised ingestion. Dosing devices for infants will be calibrated oral syringes and for older children, calibrated dosing cups will be used.

That 2009 advisory committee meeting found that errors involving acetaminophen use in children are commonly caused by parents’ confusion about how much to dose, though CHPA cited research finding only 5% of all APAP-related overdosing in children were due to parent error; the vast majority of overdosing cases resulted from accidental ingestion.

APAP is the most commonly used children’s medicine for relieving pain and reducing fever, according to the CHPA. Estimates suggested that in any given week, approximately 12% of children up to age 11 years have taken acetaminophen. The peak of acetaminophen use is among children ages 6 months to 23 months of age, according to the association’s meeting materials.

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