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PEDIATRICS Vol. 113 No. 2 February 2004, pp. 421-422

Risperidone-Associated Diabetes Mellitus in Children

Elizabeth A. Koller, MD
James T. Cross, MS
Bruce Schneider, MD
Division of Metabolic and Endocrine Drug Products; Center for Drug Evaluation and Review; Food and Drug Administration; Rockville, MD 20857, USA

The first 20% of the full text of this article appears below.

To the Editor.—

The elegant trial by Turgay et al1 highlights the emerging promise of risperidone to treat behavioral disturbances in children. Although the study found that risperidone was useful and safe in children for up to 48 weeks, weight gain was reported to have occurred in 36% of subjects. Because of the lack of a control group, the authors speculate that about half of the 8.5 kg gained was due to normal growth rather than an adverse drug effect.1 These findings are of interest, because significant weight gain may lead to hyperlipidemia or diabetes. Although there were no cases of treatment-emergent diabetes reported in the study by Turgay et al,1 risperidone-associated diabetes has been reported previously in adults2,3 and a mechanism proposed.4 To our knowledge, there are no published reports of risperidone-associated diabetes in children.

We queried the Food and Drug Administration’s . . . [Full Text of this Article]


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