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

Adverse events during first three years of marketing

•Reports for each of these 10 drugs from the first 3 years of their U.S. marketing were reviewed individually •Conventional way of comparing drugs where reporting may be most similar •For these drugs, time periods being compared have limited pediatric use •Secular trends and FDA reporting systems changes over the time period introduce significant variability into comparison

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