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Between 1997 and 2003, new federal laws encouraged manufacturers to conduct pharmacokinetic and other drug studies in the pediatric population and allowed the U.S. Food and Drug Administration to mandate such studies. These researchers reviewed studies for 108 products that were submitted to the FDA through October 2005 and had subsequent labeling changes. In their report, the authors highlighted 16 products, including several used in psychiatry.
Steady-state plasma levels of fluvoxamine were more than twice as high in children than in adolescents, consistent with slower clearance — and the need for lower doses — in the younger children. Among 8- to 11-year-olds, levels were higher in girls than in boys. For fluoxetine and its metabolite nor…