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U.S. Department of Health and Human Services


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Rilutek (riluzole) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009


Summary View



Liver Injury / Monitoring Liver Chemistries
  • In postmarketing experience, cases of clinical hepatitis associated with riluzole have been reported, including one with fatal outcome.


Use in Patients with Concomitant Disease
  • Rilutek should be used with caution in patients with concomitant liver insufficiency.  In particular, in cases of Rilutek-induced hepatic injury manifested by elevated liver enzymes, the effect of the hepatic injury on Rilutek metabolism is unknown.


Other Adverse Events Observed During All Clinical Trials/ Immune System Disorders
  • anaphylaxis