Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Archives of Clinical Psychiatry |
Texto Completo: | https://www.revistas.usp.br/acp/article/view/121758 |
Resumo: | 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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Archives of Clinical Psychiatry |
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Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review 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. Universidade de São Paulo. Faculdade de Medicina. Instituto de Psiquiatria2016-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/acp/article/view/12175810.1590/0101-60830000000086Archives of Clinical Psychiatry; v. 43 n. 3 (2016); 60-66 Archives of Clinical Psychiatry; Vol. 43 No. 3 (2016); 60-66 Revista de Psiquiatria Clínica; Vol. 43 Núm. 3 (2016); 60-66 1806-938X0101-6083reponame:Archives of Clinical Psychiatryinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/acp/article/view/121758/118632Copyright (c) 2016 Archives of Clinical Psychiatryinfo:eu-repo/semantics/openAccessMartínez-Aguayo, Juan CarlosArancibia, MarceloConcha, SebastiánMadrid, Eva2016-10-10T12:36:24Zoai:revistas.usp.br:article/121758Revistahttp://www.hcnet.usp.br/ipq/revista/index.htmlPUBhttps://old.scielo.br/oai/scielo-oai.php||archives@usp.br1806-938X0101-6083opendoar:2016-10-10T12:36:24Archives of Clinical Psychiatry - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review |
title |
Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review |
spellingShingle |
Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review Martínez-Aguayo, Juan Carlos |
title_short |
Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review |
title_full |
Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review |
title_fullStr |
Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review |
title_full_unstemmed |
Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review |
title_sort |
Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review |
author |
Martínez-Aguayo, Juan Carlos |
author_facet |
Martínez-Aguayo, Juan Carlos Arancibia, Marcelo Concha, Sebastián Madrid, Eva |
author_role |
author |
author2 |
Arancibia, Marcelo Concha, Sebastián Madrid, Eva |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Martínez-Aguayo, Juan Carlos Arancibia, Marcelo Concha, Sebastián Madrid, Eva |
description |
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. |
publishDate |
2016 |
dc.date.none.fl_str_mv |
2016-06-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.revistas.usp.br/acp/article/view/121758 10.1590/0101-60830000000086 |
url |
https://www.revistas.usp.br/acp/article/view/121758 |
identifier_str_mv |
10.1590/0101-60830000000086 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://www.revistas.usp.br/acp/article/view/121758/118632 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2016 Archives of Clinical Psychiatry info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2016 Archives of Clinical Psychiatry |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Medicina. Instituto de Psiquiatria |
publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Medicina. Instituto de Psiquiatria |
dc.source.none.fl_str_mv |
Archives of Clinical Psychiatry; v. 43 n. 3 (2016); 60-66 Archives of Clinical Psychiatry; Vol. 43 No. 3 (2016); 60-66 Revista de Psiquiatria Clínica; Vol. 43 Núm. 3 (2016); 60-66 1806-938X 0101-6083 reponame:Archives of Clinical Psychiatry instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Archives of Clinical Psychiatry |
collection |
Archives of Clinical Psychiatry |
repository.name.fl_str_mv |
Archives of Clinical Psychiatry - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
||archives@usp.br |
_version_ |
1800237623823826944 |