Abstract
American culture places a great value on our children. In accordance with this, parents seek out the best health care, wanting to ensure the well-being of their children. Despite this, physicians have been forced to treat children with medications lacking FDA indications for pediatric use. Off-label use to treat childhood disorders has been the rule rather than the exception, with clinicians relying on limited literature or clinical lore to make important medical decisions. The treatment of psychiatric disorders in children has been no exception. Medications approved for adults gradually make their way into the armamentarium of child and adolescent psychiatrists, often without adequate dosing guidelines. The past two decades have seen a dramatic increase in the number of studies looking specifically at pediatric psychopharmacology, but there have been difficulties in obtaining funding for such work. Pediatric studies have also been hampered by the lack of understanding of the biologic nature of many psychiatric disorders. Numerous factors have worked together to begin changing these problems. In 1994, the FDA enacted the Pediatric Labeling Regulation, which encouraged pharmaceutical firms to submit applications for a change in labeling for pediatric indications if a review of the literature showed that enough data existed to warrant a pediatric indication.
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