The Food and Drug Administration (FDA) must approve all medications in the United States, including what the drug is intended to treat and who it is safe to use in. Off-label use of a medication is when a physician prescribes a mediation for a different reason or indication, or to a different patient population than the medication is formally approved for.
For example, your child's physician may prescribe Zoloft (sertraline) for your child's major depressive disorder even though it is not currently FDA-approved for use in children.
Only a physician can make the decision to prescribe a medication for your child. They will weigh the risks and benefits of off-label use and consider your child's specific circumstances.
Off-label use of medications for depression in children is not uncommon. There are few medications approved for depression in children. However, research on children is helping to fill this gap. As such, physicians may choose to prescribe a medication for a child if they believe that it will benefit her specific case.
As with any depression medication, children using an off-label medication should be closely monitored by a physician, especially during the initial phase of the treatment.
Sources:
Food and Drug Administration. Manual of Policies and Procedures. Accessed: June 14, 2011. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM079936.pdf
National Institute of Mental Health. Treatment of Children With Mental Illness. Accessed: June 14, 2011. http://www.nimh.nih.gov/health/publications/treatment-of-children-with-mental-illness-fact-sheet/index.shtml
Tracy Hampton, PhD. Pediatric Drug Trials Required By Law. Medical News & Perspectives. Journal of the American Medical Association. January 28, 2004. 291(4): 411-412.
