ABSTRACT
It has become increasingly clear that there is little, if any, safety and efficacy data in the pediatric age group for the majority of prescription medications. Indeed, most medications are not labeled for use in children by the Food and Drug Administration (FDA) because of the absence of sufficient studies. In a recent review, the Committee on Drugs of the American Academy of Pediatrics (AAP; 1995) cited data from an FDA report (Office of Drug Evaluation Statistical Report, FDA, 1989) that 80% of the new medications approved from 1984 to 1989 did not contain labeling for use in children. Additionally, the AAP noted that of the medications reviewed in the 1991 Physician's Desk Reference (PDR), 81% had descriptions that either disclaimed their use in children or restricted them to specific age groups (Gilman & Gal, 1992).
