Anti-epileptics Required To Add Risk Of Suicidality Warning, REMS
FDA is requiring manufacturers of anti-epileptic drugs to add a warning of increased risk of suicidality to products' labeling, as well as submit a Risk Evaluation and Mitigation Strategy, including a Medication Guide. The action includes all AEDs, including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.
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