Psychopharmacologic Drugs Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee February 2, 2004 Postmarketing spontaneous reports of suicidal events associated with pediatric use of antidepressant drugs

Methods

•AERS database search:

Adverse event terms (from MedDRA dictionary)

•Depression suicidal

•Gun shot wound

•Intentional self-injury

•Non-accidental overdose

•Overdose NOS

•Self injurious behavior

•Self injurious ideation

•Self-mutilation

•Suicidal ideation

•Suicide attempt

•Completed suicide