Abstract
Background 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.
Highlights
2 to 3% of children and 6 to 8% of teenagers suffer from major depressive disorder, considered the main determinant of suicide, and a leading cause of death among teenagers[1]
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
The current Food and Drug Administration (FDA) warning alludes to an increase in suicidality, a vague concept ranging from mere ideation to the completion of suicide[10,11], despite the lack of epidemiologic evidence showing a relationship between suicide rates and the prescription of new AD medications[15]. This intent of this review is to provide a critical viewpoint concerning the FDA warning, its supporting evidence in terms of therapeutic (AD prescription) and epidemiological outcome, the studies that support it, and the research that reinforces the usage of AD
Summary
2 to 3% of children and 6 to 8% of teenagers suffer from major depressive disorder, considered the main determinant of suicide, and a leading cause of death among teenagers[1]. The introduction of new antidepressants (AD), selective serotonin reuptake inhibitors (SSRI) have been a useful mechanism in the rehabilitation of depression, with some countries observing a decrease in suicide rates[7]. Until the 1980s, depression was primarily treated with AD such as monoamine oxidase inhibitors and tricyclics Since overdoses of these drugs are potentially lethal, in some cases they were even used as a way to carry out suicidal acts, a situation still worrisome among prescribers, and which opened a discussion surrounding suicidality[8,9,10]. 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. It would be appropriate to consider that suicide rates might increase as a consequence of the warning
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
