Antidepressant and Suicidality
- Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in short term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders.
- Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
- Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
- Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
- Patients of all ages who are started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.
- Families and care givers should be advised of the need for close observation and communication with the prescriber.
- This drug is not approved for use in pediatric patients.
- See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Close observation for suicidal thinking or unusual changes in behavior
FDA and Industry Communications
- FDA Public Health Advisory: Antidepressant Use in Children, Adolescents, and Adults
- FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications (May 2007)
Patient Counseling Information
Updated January 2018