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FDA revises antidepressant black boxes

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Class labeling for antidepressants is updated Aug. 2 to include warnings about increased risks of suicidality in young adults ages 18 to 24. The new language, which FDA proposed in May, states that risk was not seen in adults older than 24 and that the risk decreased for adults ages 65 and older. Also added is a statement that "Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide." The Psychopharmacologic Drugs Advisory Committee recommended the changes at a 2006 meeting on the risk of drug-related suicidality in adults. The black box warning on suicidality in pediatric patients was first added in 2005...

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