A Johns Hopkins University study suggests that many anesthesia drugs used for children are not approved by FDA labels for pediatric use. Of the 106 drugs administered during anesthesia to pediatric patients in the analysis, 36 lacked FDA labeling for pediatric use. Forty of these drugs were FDA-labeled for all pediatric use and 30 had FDA labeling for use in only specific age groups. Off-label administration was observed in 73.4% of cases in the study.
Abstract: Anesthesia & Analgesia, November 2012.