@article{ref1,
title="Risk of suicidality during antidepressant treatment of children and adolescents",
journal="Primary psychiatry",
year="2006",
author="Goodman, W.K. and Murphy, T.K. and Lazoritz, M.",
volume="13",
number="1",
pages="43-50",
abstract="This article will review evidence that led the Food and Drug Administration to issue a black-box warning about the risk of suicidality (suicidal thoughts and behavior) in children and adolescents during treatment with antidepressants. Reanalysis of data from randomized clinical trials of antidepressants in the pediatric population revealed a significantly greater risk of suicidality for drug groups (4%) compared to placebo groups (2%) in a sample of approximately 4,000 subjects. There were no completed suicides. The small but statistically significant risk of suicidality was not restricted to subjects being treated for depression. With respect to efficacy, only three (20%) of 15 antidepressant trials submitted to the FDA for pediatric depression demonstrated superiority of drug over placebo. The essential message of the black-box warning is to remind prescribers and consumers about the importance of monitoring patients closely for adverse behavioral changes during the initiation of (or changes in) antidepressant therapy. Implications of the FDA actions for clinical practice will also be addressed.<p /><p>Language: en</p>",
language="en",
issn="1082-6319",
doi="",
url="http://dx.doi.org/"
}