Pediatric Information in Drug Product Labeling

Abstract

To the Editor: The dearth of information on drugs for children led to children being called "therapeutic orphans."In 1975, Wilson determined that 78% of drug labeling had inadequate pediatric information. 1In 1999, Wilson summarized 25 years of efforts to get pediatric information into labeling and extended his analysis. 2In the decade after Wilson's review, regulations and legislation have led to more pediatric studies and labeling. 3We hypothesized that a higher percentage of labeling has information on use in children compared with the analyses by Wilson in 1975 1 and in 1999. 2Methods.We evaluated labeling in the June 2009 electronic Physicians' Desk Reference 4 (ePDR) using methods established by Wilson 1 in analyzing the 1973 print PDR.Labeling was categorized as adequate if it stated that the drug was approved for pediatric use, had been studied, or had safety, efficacy, or dosing information for all appropriate pediatric populations; and inadequate if labeling lacked data on dosing, safety, or efficacy in at least 1 pediatric subpopulation.Partially labeled was a subgroup of inadequately labeled and defined as adequate labeling for at least 1 but not all appropriate pediatric subpopulations.Labeling in the ePDR was reviewed by 3 people (A.N.S., D.A., W.R.).Differences were reviewed by a fourth person who made final assignments (M.D.M.).The was 0.91.Topicals, nasal sprays and most over-the-counter products were excluded per the methods of Wilson.In products with multiple formulations, only 1 likely to be used in children (ie, oral formulation) was analyzed.Because limitations in the ePDR may lead to an underestimate of pediatric labeling, 2 subanalyses were performed.First we excluded products on the US Food and Drug Administration's (FDA's) list of Products Deemed Not Relevant to Pediatrics. 5 Second, we compared the ePDR list with the FDA's Pediatric Labeling Changes Table (February 1998-June 2009), which reflects only pediatric legislative initiatives and is not comprehensive, to determine whether most new pediatric labeling changes were included in the ePDR. 3 Similar to Wilson, 2 we also assessed the labeling for all new molecular entities (NMEs) approved between 2002 and 2008 6 to determine if the product might be used in pediatrics and the adequacy of the pediatric information.