PEDIATRICS Vol. 98 No. 1 July 1996, pp. 118-123
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Is the "Therapeutic Orphan" About to Be Adopted?

Charles J. Coté MD1, Ralph E. Kauffman MD2, Gloria J. Troendle MD3, and George H. Lambert MD4

1 Department of Anesthesia, Children's Memorial Hospital, Northwestern University Medical School, Chicago, IL 60614
2 Departments of Pediatrics and Pharmacology, Children's Mercy Hospital, Kansas City, MO 64108
3 Division of Metabolic and Endocrine Drug Products, Food and Drug Administration, Rockville, MD 20857
4 Department of Pediatrics, Clinical Research Center, University of Medicine and Dentistry of New Jersey, Piscataway, NJ 08855

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.

BACKGROUND

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.

Submitted on March 7, 1996
Accepted on April 4, 1996




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