In this issue of Pediatrics, the Committee on Drugs (COD) has examined the continued problem of the "unapproved" use of "approved" medications in pediatrics.1 This commentary will expand on the issues that have restricted drug research in children and describe current initiatives to facilitate and encourage such research to achieve the necessary drug labeling to reduce unapproved uses of medications in children.
Physicians who treat infants and children frequently prescribe medications that have never been approved by the Food and Drug Administration (FDA) for pediatric patients; unfortunately, many drugs are released without labels for pediatric use and often with pediatric disclaimers.
- Received March 7, 1996.
- Accepted April 4, 1996.
- Copyright © 1996 by the American Academy of Pediatrics