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J&J/Alza Concerta long-term data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Interim results of long-term, open-label study of once-daily Concerta show no adverse effect on growth (weight and height), J&J maintains. Labeling for the extended-release methylphenidate product currently carries a class warning that long-term suppression of growth has been reported with long-term stimulant use in children, although a causal relationship has not been established. Labeling also states that efficacy for long-term use has not been systematically evaluated. The 407-patient study, which appears in the April issue of the Journal of the American Academy of Child & Adolescent Psychiatry, showed continued response in children (ages six to 13 years) with ADHD for up to 12 months. The firm also said results show Concerta "apparently had little impact on parental perception of sleep quality" despite its extended-release profile. The study will continue through 24 month
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