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

• Published in: Child and adolescent psychiatry and mental health Vol. 2; no. 1; p. 24
• Main Authors: Zito, Julie M, Derivan, Albert T, Kratochvil, Christopher J, Safer, Daniel J, Fegert, Joerg M, Greenhill, Laurence L
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15-09-2008; BioMed Central; BMC
• Subjects: Adverse and side effects; Child psychiatry; Children; Drugs; Health aspects; Management; Off-label prescribing; Patient monitoring; Review; United States
• ISSN: 1753-2000; 1753-2000
• DOI: 10.1186/1753-2000-2-24

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.