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

Interpretation of AERS reports, continued

•In general, AERS data are most useful for distinctive or rare adverse drug reactions (e.g., aplastic anemia)

•MOST IMPORTANT limitation for this issue: Outcome of interest (suicidality) is also an outcome of the psychiatric disorders for which these drugs are prescribed

–