Off-Label Use of Medications in Children Undergoing Sedation and Anesthesia

BACKGROUND: Many drugs used for anesthesia and analgesia in children are administered off-label. We undertook an audit of drugs commonly used for pediatric anesthesia to determine which drugs have United States Food and Drug Administration (FDA) labeling for pediatric use, which drugs are age-restricted, and which have no labeling for pediatric use. METHODS: We identified drugs administered during anesthesia to pediatric patients from the operating room pharmacy. FDA approval and indications were determined by using the Thomson Micromedex (R) online database. Drugs without FDA approval for pediatric use were further examined for strength of evidence and strength of recommendation for their listed indications in the database. We then examined the rate of off-label drug administration to patients younger than the age of 18 years between July 1, 2010, and August 31, 2011. RESULTS: One hundred six drugs were identified. Thirty-six (34%) were not FDA-labeled for use in any pediatric age group, 40 (38%) were FDA-labeled for use in all pediatric age groups, and 30 (28%) were FDA-labeled for use in only specific age groups. Drugs were administered off-label in 73.4% of cases. Of those not labeled for any pediatric age group, some were among the most commonly used drugs in pediatric anesthesia, including neostigmine, hydromorphone, and dopamine. CONCLUSIONS: Many drugs used for children during anesthesia continue to lack FDA labeling for pediatric use. Off-label use of these drugs is an accepted practice that is considered superior to the alternative of withholding needed medications. Studies are still needed to determine the safety and efficacy of drugs that lack FDA labeling for this vulnerable patient population. (Anesth AnaIg 2012;115:1148-54)