Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review



Document title: Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review
Journal: Archives of clinical psychiatry
Database: PERIÓDICA
System number: 000402054
Authors: 1
1
1
1
Institutions: 1Universidad de Valparaíso, Facultad de Medicina, Valparaíso. Chile
Year:
Season: May-Jun
Volumen: 43
Number: 3
Pages: 60-66
Country: Brasil
Language: Inglés
Document type: Artículo
Approach: Analítico, descriptivo
English abstract 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. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods 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. Results 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. Discussion 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
Disciplines: Medicina
Keyword: Farmacología,
Psiquiatría,
Antidepresivos,
Inhibidores de la recaptación de serotonina,
Venlafaxina,
Suicidio,
Regulación sanitaria
Keyword: Medicine,
Pharmacology,
Psychiatry,
Antidepressants,
Serotonin uptake inhibitors,
Venlafaxine,
Suicide,
Sanitary regulation
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