Citation

Goodman WK, Murphy TK, Lazoritz M. Prim. Psychiatry 2006; 13(1): 43-50.

Copyright

(Copyright © 2006, MBL Communications)

DOI

unavailable

PMID

unavailable

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.

Language: en

Keywords

adolescent; human; child; insomnia; suicidal ideation; depression; major depression; suicidal behavior; review; clinical practice; antidepressant agent; citalopram; clomipramine; fluoxetine; fluvoxamine; mirtazapine; nefazodone; paroxetine; serotonin uptake inhibitor; sertraline; tricyclic antidepressant agent; venlafaxine; anxiety disorder; drug safety; placebo; drug efficacy; beta adrenergic receptor blocking agent; drug tolerability; irritability; side effect; obsessive compulsive disorder