Abstract

Historically, drugs prescribed for children have not been studied rigorously to assess their efficacy and safety, or appropriateness of dosing regimens. The passage of the Federal Drug Administration Modernization Act in 1997 heralded an era of increased rigor with respect to pediatric drug development by providing financial incentives to industry sponsors for conducting pharmaceutical trials in children. Subsequent legislative efforts have facilitated ongoing attention to this area. Antihypertensive drugs represent one of the largest groups of medications impacted by these efforts. Consequently, a growing number of antihypertensive medications from different classes have been studied in children and adolescents, resulting in more of these agents receiving FDA-approved labeling for use in children and adolescents.

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