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FDA REQUESTS AGE/WEIGHT RECOMMENDATIONS FOR OTC PEDIATRIC DOSING

Executive Summary

FDA REQUESTS AGE/WEIGHT RECOMMENDATIONS FOR OTC PEDIATRIC DOSING in separate letters dated November 23 to the American Academy of Pediatrics, the Proprietary Association, and McNeil Labs. "The agency needs further input concerning the uniformity of corresponding age and weight ranges if the age and weight ranges in the June 20, 1988 pediatric dosing document are out of date to arrive at a consensus in the medical community and the OTC drug industry regarding these matters," the letter from OTC Division Director William Gilbertson states. FDA explained that it is trying to resolve concerns raised by Arno Zaritsky, MD, University of North Carolina, at a Sept. 1 OTC Feedback meeting regarding the accuracy of the agency's age and weight data for pediatric dosing ("The Pink Sheet" Sept. 5, T&G-9). According to the letter, Zaritsky pointed out at the meeting that the age ranges and corresponding weight ranges submitted to FDA and published in the June 20, 1988 Federal Register "do not agree with the 1979 National Center for Health Statistics data." Zaritsky noted that weight ranges adopted by FDA are too low for the age ranges. FDA is asking the associations and McNeil whether "additional changes in corresponding ranges [would] be necessary whenever new National Center for Health Statistics data are published in the future?" The source of the data on age and weight correlations used by FDA in the Federal Register notice is identified in the letter as McNeil's Anthony Temple, MD, one of the letter's recipients. The June 20 Federal Register notice requested data on pediatric dosing regimens for all OTC products ("The Pink Sheet" June 27, T&G-5). The Sept. 1 OTC Feedback meeting was the first on the issue held by the agency. Another meeting is scheduled for December 20, where representatives from Rich-Vicks will present pediatric dosing data. Another concern of FDA's is whether height, due to its greater correlation to lean body mass than weight, is a more accurate measure for determining appropriate pediatric dosing. "It is the lean body mass rather than the actual body mass that is important in determining appropriate dosages for drugs that distribute in extracellular water," the letter states. FDA noted the potential for overdosing obese children because their lean body mass is considerably lower than their apparent body weight. The letter also points out that weight-based dosaging may result in overdosage of short children, while tall children may be underdosed.
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