Citation

Lenzer J. Br. Med. J. BMJ 2006; 332(7542): 626.

Copyright

(Copyright © 2006, BMJ Publishing Group)

DOI

10.1136/bmj.332.7542.626-c

PMID

16543313

Abstract

Children and adolescents treated with antidepressants are nearly twice as likely to develop suicidality, suicidal thinking and behaviour as similar children treated with placebo. This is the finding of a meta-analysis of 24 studies by the US Food and Drug Administration. The studies tested 4,582 patients taking nine antidepressants versus placebo for major depressive disorder, obsessive-compulsive disorder, generalised anxiety disorder, attention deficit or hyperactivity disorder, and social anxiety disorder. The FDA's analysis, published in this month's Archives of General Psychiatry is the final review of data that were previously analysed but not released by the FDA (2006;63:332-9). News of the secret data emerged in August 2004, and led to criticism of the FDA when it was learnt that Andrew Mosholder, an expert in the FDA's office of drug safety, concluded that antidepressants doubled the risk of suicidality in children, but he was not allowed to publish his findings.