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