6
Scope of FDA’s Review of Pediatric Suicidality Data
•Nine drugs included in review: 
–Prozac (fluoxetine)
–Zoloft (sertraline) 
–Paxil (paroxetine)
–Luvox (fluvoxamine)
–Celexa (citalopram)  
–Wellbutrin (bupropion)  
–Effexor (venlafaxine)
–Serzone (nefazodone) 
–Remeron (mirtazapine)    
•-25 studies:
–16 in major depressive disorder
–4 in obsessive compulsive disorder
–2 in generalized anxiety disorder
–1 in social anxiety disorder
–2 in ADHD
•Over 4000 patients