Suicidal Thoughts and Behaviors
- Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants.
- Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1)
- This drug is not approved for use in pediatric patients(8.4).
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Close observation for suicidal thinking or unusual changes in behavior
FDA and Industry Communications
Patient Counseling Information
Updated February 2022