Suicidal Thoughts and Behaviors
- Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
- Desvenlafaine-XR and venlafaxine-XR is not approved for use in pediatric patients.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.
- Families and caregivers should be advised of the need for close observation and communication with the prescriber.
FDA and Industry Communications
Drug Approval with Black Box February 2008
Patient Counseling Information
Updated August 2022