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 trend toward reduced risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)].
- In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)].
- EMSAM is contraindicated in patients less than 12 years of age because of an increased risk of hypertensive crisis [see Contraindications (4) and Use in Specific Populations (8.4)].
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Close observation for suicidal thinking or unusual changes in behavior
Patient Counseling Information
Updated January 2018