SPOTLIGHT: FDA expands antidepressant black box warning


The FDA announces it will expand the black box warnings on antidepressant drugs to "include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment." Previously the FDA warned antidepressants could cause suicidal behavior in children. The FDA had debated how to clarify the warning, as antidepressant sales have dropped 13 percent since the black box was added. The "important message going forward is that these drugs have value across the age spectrum, but that patients must be monitored especially early in treatment," noted Thomas Laughren of the FDA's psychiatry products division. Warning | Article (WSJ sub. req.)

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