Expanding the Black Box — Depression, Antidepressants, and the Risk of Suicide

Andrew C. Leon

174 citations0/0 files storedNew England Journal of Medicine

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Suicide and Self-Harm Studies Pharmacovigilance and Adverse Drug Reactions Treatment of Major Depression

Abstract

On May 2, the FDA ordered that all antidepressant medications carry an expanded black-box warning incorporating information about an increased risk of suicidal symptoms in young adults 18 to 24 years of age. Dr. Richard Friedman and Andrew Leon write that this new label has the potential to confuse both patients and physicians. Dr. Andrew Leon discusses the expansion of the black-box warning for antidepressants to cover the risk of suicidality among young adults, the suicidality risk associated with depression, and the data available for assessing these risks. Dr. Leon is a professor of biostatistics in psychiatry and a professor of public health at Weill Cornell Medical College, New York, and a member of the FDA's Psychopharmacologic Drugs Advisory Committee.

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References

2006Suicidality in Pediatric Patients Treated With Antidepressant Drugs 2006The Relationship Between Antidepressant Prescription Rates and Rate of Early Adolescent Suicide

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2015Antidepressant use and risk of suicide and attempted suicide or self harm in people aged 20 to 64: cohort study using a primary care database 2012A systematic review of validated methods for identifying suicide or suicidal ideation using administrative or claims data 2009Clinical correlates of the worsening or emergence of suicidal ideation during SSRI treatment of depression: An examination of citalopram in the STAR⁎D study 2007Early intervention for depressive disorders in young people: the opportunity and the (lack of) evidence 2018Blended cognitive behavior therapy : efficacy and acceptability for treating depression in the adult and adolescent population

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