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U.S. Department of Health and Human Services

Safety

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Fycompa (perampanel) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Psychiatric and Behavioral Reactions
  • Homicidal ideation and/or threat were exhibited in 0.1% of 4,368 perampanel treated patients in controlled and open label studies, including non-epilepsy studies.