Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2008 Sep 15;2(1):24.
doi: 10.1186/1753-2000-2-24.

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

Julie M Zito  1 , Albert T Derivan, Christopher J Kratochvil, Daniel J Safer, Joerg M Fegert, Laurence L Greenhill
Affiliations

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

Julie M Zito et al. Child Adolesc Psychiatry Ment Health. .

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.

PubMed Disclaimer

References

    1. Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labeling. JAMA. 2003;290:905–911. doi: 10.1001/jama.290.7.905. - DOI - PubMed
    1. Turner S, Nunn AJ, Choonara I. Unlicensed drug use in children in the UK. The International Journal of Pharmacy. 2004. http://www.priory.com/pharmol/uduiciuk.htm
    1. Fost N. Ethical issues in research and innovative therapy in children with mood disorders. Biol Psychiatry. 2001;49:1015–1022. doi: 10.1016/S0006-3223(01)01181-7. - DOI - PubMed
    1. Behrman RE, Kliegman RM, Jenson HB. Nelson Textbook of Pediatrics. 17. Elsevier Science; 2003.
    1. Brunton LL, Lazo JS, Parker KL. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 11. The McGraw-Hill Companies; 2006.

LinkOut - more resources