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

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.