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More Methylphenidate Adverse Events in Preschoolers

Side effects reported by 30 percent of parents

TUESDAY, Oct. 24 (HealthDay News) -- The tolerability of methylphenidate is lower than expected among preschool children with attention-deficit/ hyperactivity disorder (ADHD), and they may have more emotional outbursts, insomnia and repetitive behavior than older children, according to a report in the November issue of the Journal of the American Academy of Child & Adolescent Psychiatry.

Tim Wigal, Ph.D., of the University of California - Irvine, and colleagues conducted a study of 183 children aged 3 to 5 years. All the children participated in a one-week open-label lead-in, then 165 children took part in a five-week placebo-controlled double-blind phase, 114 completed a five-week double-blind, parallel phase, and 140 children started 10 months of open-label maintenance, with 95 completing the course.

In all study phases after baseline, 30 percent of parents reported adverse events ranging from moderate to severe, including emotional outbursts, insomnia, repetitive behavior and thoughts, reduced appetite and irritability. In all, 21 children, or 11 percent, left the study due to drug-attributed adverse events.

"Tolerability of methylphenidate for preschoolers was lower than expected," the authors conclude. "Although some adverse events diminish over time (e.g., irritability, emotionality), those preschoolers with ADHD on methylphenidate treatment still need to be carefully monitored."

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