Pediatric Content in Drug Labeling Has Increased

But only 46 percent of drugs listed in the Physicians' Desk Reference have pediatric information

WEDNESDAY, May 9 (HealthDay News) -- Pediatric content in the labeling of drugs has improved from 1975 to 1999, but still only 46 percent of drug labeling in the electronic Physicians' Desk Reference (ePDR) includes pediatric information, according to research published in the May 9 issue of the Journal of the American Medical Association.

Aaron N. Sachs, from the U.S. Food and Drug Administration in Silver Spring, Md., and colleagues applied methods established by John T. Wilson, M.D., in his 1973 analysis of the print PDR to evaluate labeling in the June 2009 ePDR. Labeling was "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. Labeling was "inadequate" if it lacked data on dosing, safety, or efficacy in at least one pediatric subpopulation. "Partially labeled" was defined as adequate labeling for at least one but not all pediatric subpopulations.

The researchers analyzed 560 products in the ePDR. Of those, 231 (41 percent) were adequately labeled and 29 (5 percent) were partially labeled for pediatric use. If products deemed not relevant to pediatric use were excluded from the analysis, 231 of 461 (50 percent) were adequately labeled for pediatric use and 29 (6 percent) were partially labeled.

"Labeling with pediatric information in only 46 percent of products is still insufficient," the authors conclude. "Legislation to increase pediatric clinical trials and require the resulting information be added to labeling is necessary."

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