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FDA Requests Suicidality Event Review For Epilepsy Drugs

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA is requesting that 14 manufacturers of anti-epileptic drugs re-examine clinical trial data to identify potential suicide-related adverse events. The analyses will be modeled on the agency’s recent re-examination of antidepressant data. FDA’s request to epilepsy drug sponsors follows suicidality signals seen in some trials.
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