Suicide Rates in Clinical Trials of SSRIs, Other Antidepressants, and Placebo: Analysis of FDA Reports

Khan, Arif; Khan, Shirin; Kolts, Russell L.; Brown, Walter A.

doi:10.1176/appi.ajp.160.4.790

Cited by 330 publications

(188 citation statements)

References 8 publications

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“…Although Khan et al 73 and Gunnell et al 74 concluded that there was not an impact on suicide secondary to the use of AD, there was an increase of self-aggressive behaviors. Some proposed mechanisms to explain the relationship among AD, ideas, and suicidal behaviors 75,76 , are psychomotor stimulation, depression paradoxical deterioration, akathisia, panic attack or anxiety onset, pharmacological switch to mania, induction to obsessive concern with suicide, and aggressive "borderline reactions" or paroxysmal disorders to electroencephalogram that might alter impulse control 61,[73][74][75][76] .…”

Section: Discussionmentioning

confidence: 98%

“…Some proposed mechanisms to explain the relationship among AD, ideas, and suicidal behaviors 75,76 , are psychomotor stimulation, depression paradoxical deterioration, akathisia, panic attack or anxiety onset, pharmacological switch to mania, induction to obsessive concern with suicide, and aggressive "borderline reactions" or paroxysmal disorders to electroencephalogram that might alter impulse control 61,[73][74][75][76] . For example, AD with short half-lives may induce, initially, serotonin level fluctuations, which may lead to akathisia, therefore increasing suicidal risk associated with desperation and unrest 77 .…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

Martínez-Aguayo¹,

Arancibia²,

Concha³

et al. 2016

Arch. Clin. Psychiatry (São Paulo)

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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.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

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

Martínez-Aguayo¹,

Arancibia²,

Concha³

et al. 2016

Arch. Clin. Psychiatry (São Paulo)

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“…In 1987, fluoxetine entered the market, but only in 2003 were SSRIs approved for use in children. In 2004, use of SSRIs increased and the idea that SSRIs might increase suicidal ideation was introduced in the public press [7][8][9]. Scharf commented that the issues around suicidal ideation were complicated by commercial influences and by the selection criteria used to recruit subjects for antidepressant trials.…”

Section: Can We Treat Adolescents With Ssris?mentioning

confidence: 99%

Adolescent Brain Development and Behavior

Barr

Sandor

2010

Pediatric Health

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The symposium on ‘The Adolescent Brain Development and Behaviour’ was organized in honor of the 40th anniversary of Youthdale Treatment Clinics in Toronto. The idea for a symposium dedicated to the adolescent brain was conceived over a year ago and was stimulated by recent rapid progress in neurobiological research focused on this developmental period. Puberty is a time of dramatic physiological, cognitive and emotional changes associated with increased risk for psychiatric disorders as well as increased risk-taking behavior. The increase in risk for psychiatric disorders may be a function of biological changes in gonadal hormones, or may result from increased emotional stress, or an interaction of these factors. Brain structures show dramatic changes in myelination, synaptogenesis and synaptic pruning from late childhood to early adolescence. Learning and experience probably interact with the biologically programmed developmental influences modifying synaptic connections and region-specific structure and function. Adolescence presents significant challenges and also unique opportunities for intervention regarding psychiatric and behavioral disorders.

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“…In an analysis of the FDA trials, in which patients typically received medication for shorter periods of time than in clinical practice, Kahn et al 26 found no difference between antidepressants (selective serotonin reuptake inhibitors or otherwise) and placebo in terms of suicide rates. Therefore, my sense is that the amount of time that patients take medications has a lot to do with their antisuicidal effects.…”

Section: -3mentioning

confidence: 99%

Defining and Managing Suicidal Risk in Patients Taking Psychotropic Medications

Fawcett

Baldessarini²,

Coryell³

et al. 2009

J. Clin. Psychiatry

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Suicide Rates in Clinical Trials of SSRIs, Other Antidepressants, and Placebo: Analysis of FDA Reports

Abstract: These findings fail to support either an overall difference in suicide risk between antidepressant- and placebo-treated depressed subjects in controlled trials or a difference between SSRIs and either other types of antidepressants or placebo.

Cited by 330 publications

References 8 publications

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

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

Adolescent Brain Development and Behavior

Defining and Managing Suicidal Risk in Patients Taking Psychotropic Medications

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