Pediatric drug info still lacking
Pediatric Content in Drug Labeling Has Increased
HealthDay News -- Although the availability of drug information for children is improving, less than half of drugs listed in a recent edition of a major clinician drug resource included pediatric information, researchers found.
Only 46% of the products included in the 2009 electronic Physicians' Desk Reference (ePDR) included pediatric use instruction in their labeling, Debbie Avant, RPh, of the FDA in Silver Springs, Md., and colleagues reported in a research letter published in the Journal of the American Medical Association.
This figure has more than doubled from a 1975 analysis in which only 22% of drugs in the PDR included pediatric information, but is still "insufficient," the researchers noted. They called for current legislation requiring information from pediatric clinical trials to be included in drug labeling to be reauthorized after it expires this year.
The Best Pharmaceuticals for Children Act (BCPA), passed in 2002, and the Pediatric Research Equity Act (PREA) of 2003, have resulted in new pediatric labeling for almost 400 drugs as of March 2011.
To analyze labeling information from 560 products included in the June 2009 ePDR, Avant and colleagues used methodology established by John T. Wilson, MD, in the 1973 PDR study.
Labeling was deemed to be 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. Researchers classified labeling as inadequate if it lacked data on dosing, safety or efficacy in at least one pediatric subpopulation. Products were considered partially labeled if they had adequate labeling for at least one, but not all pediatric subpopulations.Overall 41% of drugs included in the analysis were adequately labeled (n=231) and 5% (n=29) were partially labeled for pediatric use. After excluding products deemed not relevant to pediatric use, 56% had some pediatric labeling, the researchers found, and after adding products from the FDA's pediatric labeling changes table, 62% had some pediatric information.
Study limitations include the exclusion of many commonly used products and those not listed in the ePDR.