Chapter 3
Page 14

Is it okay for my child to take a medication that does not have FDA approval?

  • Many medications used to treat young people with mental illness are safe and effective.
  • Many psychotropic medications, however, do not have Food and Drug Administration (FDA) approved labeling for use in children and adolescents due to the majority of medication being approved by the FDA based on research in adults.
  • Over time, clinical studies and research may support the use of the medication for an "off-label" in children and/or adolescents.
  • The DFPS prescribing Parameters include "Literature based maximum doses" for medications where there is support for "off-label" use.
  • However, many medications have not been studied or approved for use with children.  Researchers are not sure how these medications affect a child’s growing body.