Original
Report on Emergence of Suicidality
in Association with Paxil Use in
Pediatric Patients
•Request for clarification of events coded under “emotional lability” was basis for additional work done by GSK
•Resulted in submission of report on paroxetine and pediatric suicidality, first to the MHRA, and shortly thereafter, to FDA, on May 22, 2003
•Report suggested increased risk of suicidality associated with paroxetine use, especially in 1 of 3 studies in pediatric major depressive disorder