Citation

Gören JL. Expert Opin. Drug Saf. 2008; 7(3): 223-225.

Copyright

(Copyright © 2008, Informa Healthcare)

DOI

10.1517/14740338.7.3.223

PMID

18462180

Abstract

In October of 2003, the FDA issued a public health warning stating that preliminary evidence showed selective serotonin re-uptake inhibitors (SSRIs) and related antidepressants might be associated with excess reports of suicidality. In 2004, the FDA convened a committee of neuropsychiatric and pediatric subcommittee members and expert consultants to evaluate the safety of antidepressants in children and adolescents. The committee reviewed a meta-analysis of antidepressant use in pediatric patients and concluded that there was a causal link between pediatric antidepressant use and suicidality. In response, the FDA mandated that a 'black box' warning be added to the prescribing and promotional information for all antidepressants. The warning specifically states 'antidepressants increase the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders'. Interestingly, the FDA tempered the warning with the following statement: 'Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide'. Therefore, in effect, the FDA has warned that both untreated depression and treatments for depression lead to suicidality. Now, 4 years later, the repercussions of the black box warning are becoming evident.

Language: en