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

Conclusions

•For the study of pediatric suicidal behavior associated with antidepressant drug treatment:

–Utility of available pharmacoepidemiological or postmarketing surveillance data is limited

–Randomized, controlled trial data should be superior to data from these sources