PEDIATRICS Vol. 52 No. 3 September 1973, pp. 451
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EXPERIMENTAL AND "ORPHAN" DRUGS

Certain clinical studies in children, reported in recognized pediatric journals, have been accomplished with experimental drugs or with "orphan" drugs.1 In view of the caliber of the journals in which these reports have appeared, an unknown number of practitioners may be led to making similar applications of these compounds, sometimes unaware that they are not approved for such uses, or in such dosage forms, and more especially, not approved for use in children.

These situations may occur more frequently than most pediatricians realize. More than half of new drugs released between 1959 and 1971 with potential for use in children have label disclaimers for pediatric use, but many of these are used by pediatricians.2

In "Pharmacology for the Pediatrician", when clinical reports describe the unofficial use of compounds or investigative drugs, this will be clearly stated. The practitioner may thus weigh the "investigative status" of these practices against potential benefit to the patient.