[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 35.175.121.230. Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Research Letter
May 9, 2012

Pediatric Information in Drug Product Labeling

Author Affiliations

Author Affiliations: School of Medicine, University of Maryland, Baltimore (Mr Sachs); and Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland (Ms Avant and Drs Lee, Rodriguez, and Murphy) (debbie.avant@fda.hhs.gov). Mr Sachs worked at the Food and Drug Administration when this study was performed.

JAMA. 2012;307(18):1914-1915. doi:10.1001/jama.2012.3435

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.1 In 1999, Wilson summarized 25 years of efforts to get pediatric information into labeling and extended his analysis.2 In the decade after Wilson’s review, regulations and legislation have led to more pediatric studies and labeling.3 We hypothesized that a higher percentage of labeling has information on use in children compared with the analyses by Wilson in 19751 and in 1999.2

We evaluated labeling in the June 2009 electronic Physicians' Desk Reference4 (ePDR) using methods established by Wilson1 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.

×