Revised Antidepressant Labeling Drops Language On Suicide Causality
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA removes from class warning the statement that “a causal role for antidepressants in inducing pediatric suicidality has been established.” Revised “black box” specifies antidepressants demonstrated an increased risk of suicidality in “short-term studies.” FDA resets clock for manufacturers to comply with changes.
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