What difference does it make if a medication is specifically approved for use in children or not?
Approval of a medication by the FDA means that adequate data have been provided to the FDA by the drug manufacturer to show safety and efficacy for a particular therapy in a particular population. Based on the data, a label indication for the drug is established that includes proper dosage, potential side effects, and approved age. Doctors prescribe medications as they feel appropriate even if those uses are not included in the labeling. Although in some cases there is extensive clinical experience in using medications for children or adolescents, in many cases there is not. Everyone agrees that more studies in children are needed if we are to know the appropriate dosages, how a drug works in children, and what effects there are on learning and development. Q: What does “off-label” use of a medication mean? A: Many medications that are on the market have not been officially approved by the FDA for use in children. Treatment of children with these medications is called “off-label” use.
