Antidepressants and the FDA's Black-Box Warning: Determining a Rational Public Policy in the Absence of Sufficient Evidence

• DOI: 10.1001/virtualmentor.2012.14.6.pfor2-1206
• Publication Date: 2013-09-11T06:47:37Z
• Authors: Dien Ho
• Keywords: Serotonin reuptake inhibitor; Sertraline

In October of 2004, the Federal Drug Administration (FDA) issued a “black-box” label warning indicating that use certain antidepressants to treat major depressive disorder (MDD) in adolescents may increase risk suicidal ideations and behaviors. The came shortly after FDA’s British counterpart, Medicines Healthcare products Regulatory Agency (MHRA), concluded selective serotonin reuptake inhibitors (SSRIs) with exception fluoxetine (Prozac) should not be used disorders.