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The FDA "Black Box" Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits?


The FDA "Black Box" Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits?

Michele Fornaro et al. Front Psychiatry.


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.

Keywords: Bipolar Disorder; FDA; Major depression (MDD); antidepressant; suicide; “black box” warning.

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    1. WHO “World Health Organization (2009) Suicide Prevention (SUPRE)”. World Health Organization; (2000).
    1. Tsuang MT, Tohen M, Jones P. Textbook of psychiatric epidemiology. Hoboken, NJ, United States: John Wiley & Sons; (2011) 10.1002/9780470976739 - DOI
    1. Glenn CR, Kleiman EM, Cha CB, Deming CA, Franklin JC, Nock MKJD, et al. Understanding suicide risk within the Research Domain Criteria (RDoC) framework: a meta-analytic review. Depress Anxiety (2018) 35(1):65–88. 10.1002/da.22686 - DOI - PMC - PubMed
    1. Sonawalla SB, Fava MJCD. Severe Depression. CNS Drugs (2001) 15(10):765–76. 10.2165/00023210-200115100-00003 - DOI - PubMed
    1. Hankin BL, Fraley RC, Lahey BB, Waldman ID. Is depression best viewed as a continuum or discrete category? A taxometric analysis of childhood and adolescent depression in a population-based sample. J Abnorm Psychol (2005) 114(1):96–110. 10.1037/0021-843X.114.1.96 - DOI - PubMed