Comparison of Approved Dosages for Pediatric and Adult Populations Based on US Labeling Information.

Abstract

The passing of legislation in the United States and the European Union has led to the approval of dosages for pediatric use. This study was conducted in an attempt to find potentially important factors with regard to dose selection for the pediatric population. The FDA's New Pediatric Labeling Information Database was used for this study. Drug labels for patients aged 6 months as well as those for patients aged 2, 6, and 11 years were standardized based on dosages expressed by age, normalized body weight (BW), and body surface area (BSA) in order to obtain ratios of pediatric-to-adult dosages. Labeling for 108 drugs were extracted for the analysis. Ratios of pediatric-to-adult dosages based on BW were higher than 1, but those based on BSA were around 1. Relative dosages at 6 months of age showed a stronger correlation with those at 2 years compared to those at other ages. The approved dosages for pediatrics based on BW were higher than those of adults, but the ones based on BSA were almost the same as those of adults. The closer the age groups, the stronger the correlation of relative dosages between the groups.