Safety information for children missing on many drug labels

June 15, 2012

Approximately half of drug labels don’t have information on the medication’s safety and proper dosing in children, revealing an overall lack of study of children’s drug therapies, 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, says that the study reminds care providers and parents that many products still remain to be studied in children.

“Historically, drugs were not studied in children and studies in 1975 and 1999 found that about 22% of drug labeling had information on use in children,” Avant says. “Legislation in the past 10 years has led to an increase in pediatric studies and labeling. This study was done to estimate the progress made over the last decade and approximate the percentage of drugs with information on use 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, Avant says. 

“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 says.

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