FDA Post-Marketing Safety Decisions

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The U.S. Food and Drug Administration (FDA) black box warning that antidepressants increase the risk of suicidal thinking and behavior in children was followedby a sharp fall in antidepressant prescriptions. No procedure for estimating the net public health impact exists.¹ No suicide occurred in clinical trials of approximately 4400 children, but the term suicidality clearly implies a high degree of lethal risk.’ ‹