Published: 1. May, 2020

Studies are still needed to determine the safety and efficacy of drugs that lack FDA labeling for this vulnerable patient population. Drugs were administered off-label in 73.4% of cases to children.

Up to 75 percent of all medications currently prescribed in hospital settings for children are administered off-label

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. Drugs were administered off-label in 73.4% of cases.

https://pubmed.ncbi.nlm.nih.gov/22451593/