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Academic Highlights

FDA Post-Marketing Safety Decisions

Donald F. Klein, MD

Published: August 15, 2006

Article Abstract

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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.’ ‹

Volume: 67

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