BlackBoxRX
 
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Desvenlafaxine, Venlafaxine

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 [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)].
  • Desvenlafaxine is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

 


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)

Drug Approval with Black Box February 2008

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Venlafaxine

Desvenlafaxine

Additional Information

Updated January 2018