In 2004, the Food and Drug Administration (FDA) directed pharmaceutical manufacturers to add a black box warning to antidepressants describing an increased suicide risk in children. We describe the events and evidence that led the FDA to act, the specific actions taken by the agency, and the changes in treatment patterns that followed. We then consider the outcomes of this case in the context of recent regulatory changes aimed at increasing the availability of information on the efficacy and safety of prescription medications.
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