Fatal and Nonfatal Hepatotoxicity Associated with Flutamide

Objective: To identify and describe patients with hepatotoxicity possibly caused by flutamide, an antiandrogen drug. Design: Case series of reports, submitted to the Adverse Drug Event Reporting System of the Food and Drug Administration. Setting: Outpatient clinics and physicians' offices in the United States. Patients: Nineteen patients treated with flutamide for prostate cancer or benign prostatic hypertrophy (for Investigation of a New Drug or off-label use). Measurements: Evidence of increased liver enzyme levels, hyperbilirubinemia, associated clinical symptoms, and diagnoses of cholestatic hepatitis. Autopsy reports were used when available