The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits?
The decision made in the year 2004 by the U.S. Food and Drug Administration (FDA) to require a boxed warning on antidepressants regarding the risk of suicidality in young adults still represents a matter of controversy. The FDA warning was grounded on industry-sponsored trials carried one decade ago...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2019-05-01
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| Series: | Frontiers in Psychiatry |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/article/10.3389/fpsyt.2019.00294/full |
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| author | Michele Fornaro Michele Fornaro Annalisa Anastasia Annalisa Anastasia Alessandro Valchera Alessandro Valchera Alessandro Carano Alessandro Carano Laura Orsolini Federica Vellante Gabriella Rapini Luigi Olivieri Serena Di Natale Giampaolo Perna Giovanni Martinotti Massimo Di Giannantonio Domenico De Berardis Domenico De Berardis Domenico De Berardis |
| author_facet | Michele Fornaro Michele Fornaro Annalisa Anastasia Annalisa Anastasia Alessandro Valchera Alessandro Valchera Alessandro Carano Alessandro Carano Laura Orsolini Federica Vellante Gabriella Rapini Luigi Olivieri Serena Di Natale Giampaolo Perna Giovanni Martinotti Massimo Di Giannantonio Domenico De Berardis Domenico De Berardis Domenico De Berardis |
| author_sort | Michele Fornaro |
| collection | DOAJ |
| description | The decision made in the year 2004 by the U.S. Food and Drug Administration (FDA) to require a boxed warning on antidepressants regarding the risk of suicidality in young adults still represents a matter of controversy. The FDA warning was grounded on industry-sponsored trials carried one decade ago or earlier. However, within the past decade, an increasing number of reports have questioned the actual validity of the FDA warning, especially considering a decline in the prescription of the antidepressant drugs associated with an increase in the rate of suicidal events among people with severe depression. The present report provides an overview of the FDA black box warning, also documenting two Major Depressive Disorder patients whose refusal to undergo a pharmacological antidepressant treatment possibly led to an increased risk for suicidal behaviors. The concerns raised by the FDA black box warning need to be considered in real-world clinical practice, stating the associated clinical and public health implications. |
| first_indexed | 2024-12-12T20:55:53Z |
| format | Article |
| id | doaj.art-b8f6118643084103873080571abaac8f |
| institution | Directory Open Access Journal |
| issn | 1664-0640 |
| language | English |
| last_indexed | 2024-12-12T20:55:53Z |
| publishDate | 2019-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj.art-b8f6118643084103873080571abaac8f2022-12-22T00:12:18ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402019-05-011010.3389/fpsyt.2019.00294399699The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits?Michele Fornaro0Michele Fornaro1Annalisa Anastasia2Annalisa Anastasia3Alessandro Valchera4Alessandro Valchera5Alessandro Carano6Alessandro Carano7Laura Orsolini8Federica Vellante9Gabriella Rapini10Luigi Olivieri11Serena Di Natale12Giampaolo Perna13Giovanni Martinotti14Massimo Di Giannantonio15Domenico De Berardis16Domenico De Berardis17Domenico De Berardis18Neuroscience, Reproductive Science and Odontostolmatology, Section of Psychiatry, University School of Medicine Federico II, Naples, ItalyPolyedra Research Group, Teramo, ItalyPolyedra Research Group, Teramo, ItalyAlma Mater S.P.A. Villa Camaldoli, Naples, ItalyAlma Mater S.P.A. Villa Camaldoli, Naples, ItalyVilla S. Giuseppe Hospital, Hermanas Hospitalarias, Ascoli Piceno, ItalyPolyedra Research Group, Teramo, ItalyNHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital G. Mazzini, ASL Teramo, Teramo, ItalySchool of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, United KingdomNHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital G. Mazzini, ASL Teramo, Teramo, ItalyNHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital G. Mazzini, ASL Teramo, Teramo, ItalyNHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital G. Mazzini, ASL Teramo, Teramo, ItalyNHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital G. Mazzini, ASL Teramo, Teramo, ItalyHermanas Hospitalarias, FoRiPsi, Department of Clinical Neurosciences, Villa San Benedetto Menni, Como, ItalyDepartment of Neurosciences and Imaging, Chair of Psychiatry, University G. D’Annunzio, Chieti, ItalyDepartment of Neurosciences and Imaging, Chair of Psychiatry, University G. D’Annunzio, Chieti, ItalyNeuroscience, Reproductive Science and Odontostolmatology, Section of Psychiatry, University School of Medicine Federico II, Naples, ItalyPolyedra Research Group, Teramo, ItalyNHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital G. Mazzini, ASL Teramo, Teramo, ItalyThe decision made in the year 2004 by the U.S. Food and Drug Administration (FDA) to require a boxed warning on antidepressants regarding the risk of suicidality in young adults still represents a matter of controversy. The FDA warning was grounded on industry-sponsored trials carried one decade ago or earlier. However, within the past decade, an increasing number of reports have questioned the actual validity of the FDA warning, especially considering a decline in the prescription of the antidepressant drugs associated with an increase in the rate of suicidal events among people with severe depression. The present report provides an overview of the FDA black box warning, also documenting two Major Depressive Disorder patients whose refusal to undergo a pharmacological antidepressant treatment possibly led to an increased risk for suicidal behaviors. The concerns raised by the FDA black box warning need to be considered in real-world clinical practice, stating the associated clinical and public health implications.https://www.frontiersin.org/article/10.3389/fpsyt.2019.00294/fullFDAantidepressantsuicide“black box” warningMajor depression (MDD)Bipolar Disorder |
| spellingShingle | Michele Fornaro Michele Fornaro Annalisa Anastasia Annalisa Anastasia Alessandro Valchera Alessandro Valchera Alessandro Carano Alessandro Carano Laura Orsolini Federica Vellante Gabriella Rapini Luigi Olivieri Serena Di Natale Giampaolo Perna Giovanni Martinotti Massimo Di Giannantonio Domenico De Berardis Domenico De Berardis Domenico De Berardis The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? Frontiers in Psychiatry FDA antidepressant suicide “black box” warning Major depression (MDD) Bipolar Disorder |
| title | The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? |
| title_full | The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? |
| title_fullStr | The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? |
| title_full_unstemmed | The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? |
| title_short | The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? |
| title_sort | fda black box warning on antidepressant suicide risk in young adults more harm than benefits |
| topic | FDA antidepressant suicide “black box” warning Major depression (MDD) Bipolar Disorder |
| url | https://www.frontiersin.org/article/10.3389/fpsyt.2019.00294/full |
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