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

Results for first 3 years of marketing

•94 reports reviewed

•78 unduplicated reports for 9 drugs (no cases for nefazodone)

•Of the 78 reports

–Most female (77%)

–Most > 12 years old (95%)

–Most suicide attempts (86%)

•7 completed suicides

–6 fluoxetine, 1 paroxetine

–4 males and 3 females

•No reports of rechallenge with same drug