BlackBoxRX
 
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Citalopram

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

Drug Safety Communication: Abnormal Heart Rhythm Associated with High Doses (Aug 2011)

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)

FDA Medication Guide

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Citalopram

Additional Information

Updated February 2022