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Archives of Clinical Psychiatry (São Paulo)

Print version ISSN 0101-6083On-line version ISSN 1806-938X


MARTINEZ-AGUAYO, Juan Carlos; ARANCIBIA, Marcelo; CONCHA, Sebastián  and  MADRID, Eva. Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review. Arch. Clin. Psychiatry (São Paulo) [online]. 2016, vol.43, n.3, pp.60-66. ISSN 0101-6083.


The United States Food and Drug Administration (FDA) has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI) and venlafaxine in children and adolescents.


To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents.


A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates.


The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates.


Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.

Keywords : Antidepressants; serotonin uptake inhibitors; suicide; United States Food and Drug Administration.

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