Many medications have not been FDA approved for children. However,
with enough experience a physician can still prescribe this drug
for a young child. This use of a medication is called "off-label."
Most drugs prescribed for childhood mental disorders are off-label.
This is true of many of the newer medications that are proving helpful.
Very few of these drugs have been scientifically studied for use in
children. If your child is prescribed one of these drugs it will say so on
the label. It will say "Safety and efficacy have not been
established in pediatric patients." But under a doctor's
supervision it is often still okay to use this drug. If you are concerned,
talk to your doctor about the risks and benefits of using a drug.
The FDA has been urging all drugs be appropriately studied in children.
It has offered incentives to drug makers to carry out such testing.
The National Institutes of Health and the FDA are looking at the
issue of drug research in children. They are trying to develop new research approaches.
Adapted from NIMH (2002). Medications (4th edition).
NIH Publication No. 02-3929. Accessed on October 24, 2005 at
http://www.nimh.nih.gov/publicat/medicate.cfm.
