Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring – Most medications are approved for marketing based on favorable benefit to risk assessments from clinical trial data in adults. Pediatric medical practice has been primarily off-label, i.e., permissible even though the drug was not specified for this age group, or indication in the product label approved by the Food and Drug Administration (FDA). Off-label use of a drug is a common practice representing approximately 50–75% of pediatric medication use. In Europe, medication use may be characterized as either unlicensed, i.e. not approved for use in a particular age group, or off-label, i.e. outside the terms of their product license or marketing authorizations. Occasionally, products not approved for use in children have statements declaring inadequate data or have warnings in their product label of potential dangers associated with pediatric use