Many drug labels missing safety, dosing information for children

July 1, 2012

Approximately half of drug labels don't have information on the medication's safety and proper dosing in children, according to a study from FDA researchers.

Approximately half of drug labels don't have information on the medication's safety and proper dosing in children, according to a study from FDA researchers.

In the study, researchers looked at 560 medications listed in the 2009 electronic Physicians' Desk Reference, some not relevant for pediatric use, and they found only 46% referred to children's usage. When they looked only at drugs used in children, they found "adequate" labeling information for 231 of 461 drugs. "Adequate" meant they included information on drug effectiveness, safety in kids and teens, and guidance on dosing.

Although this finding is an improvement in pediatric labeling, Debbie Avant, RPh, from the Office of Pediatric Therapeutics, Office of the Commissioner, FDA, told Formulary that the study reminds care providers and parents that many products still remain to be studied in children.

Some very vulnerable populations such as neonates remain almost untouched as far as developing adequate information on how best to use therapies in this population is concerned, Avant said.

"Obviously doctors need to use these therapies and would not withhold treatment, but it does emphasize that one should think about this aspect if a child is not responding or having unexpected adverse effects from a therapy," she said.

"Continued diligence in pediatric dosing for safety, as well as effectiveness, remains an inexact science due to the paucity of drug information available for clinicians or parents to review when choosing medications to use in children," Vogenberg continued. "This issue is likely to increase in importance as more narrow therapeutic margin medications enter the marketplace along with genomic-specific products in younger-age cohorts."

This study also evaluated the labeling of new molecular entities approved between 2002 and 2008 and determined that 41% had information on use in children.

For more information on the study of drugs in the pediatric population, go to http://www.fda.gov/AboutFDA/Transparency/Basics/ucm228249.htm. For pediatric labeling changes go to http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase.