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Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring

Julie M Zito1 email, Albert T Derivan2 email, Christopher J Kratochvil3 email, Daniel J Safer4 email, Joerg M Fegert5 email and Laurence L Greenhill6 email

Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA

Psychiatry and Human Behavior, Thomas Jefferson University School of Medicine, Philadelphia, Pennsylvania, USA

Psychopharmacology Research Center, University of Nebraska Medical Center, Omaha, Nebraska, USA

Department of Psychiatry, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA

Department of Child and Adolescent Psychiatry/Psychotherapy, University Hospital Ulm, Germany

Department of Psychiatry, Columbia University Medical Center, New York, New York, USA

author email corresponding author email

Child and Adolescent Psychiatry and Mental Health 2008, 2:24doi:10.1186/1753-2000-2-24

Published: 15 September 2008

Abstract

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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