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This article has been peer reviewed and is published in BMC Child and Adolescent Psychiatry and Mental Health Volume 2, 15 September 2008, Article number 24. The published version is available at DOI: 10.1186/1753-2000-2-24. Copyright © BioMed Central Ltd.


The review presents pediatric adverse drug events from a historical perspective and focuses on selected safety issues associated with off-label use of medications for the psychiatric treatment of youth. Clinical monitoring procedures for major psychotropic drug classes are reviewed. Prior studies suggest that systematic treatment monitoring is warranted so as to both minimize risk of unexpected adverse events and exposures to ineffective treatments. Clinical trials to establish the efficacy and safety of drugs currently being used off-label in the pediatric population are needed. In the meantime, clinicians should consider the existing evidence-base for these drugs and institute close clinical monitoring.

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