Flutamide-induced acute hepatitis in advanced prostate cancer patients.

ABSTRACT

OBJECTIVE: To describe the characteristics of 3 patients hospitalized in the Department of Gastroenterology, University Hospital Center, Rijeka, as the result of acute hepatitis, a rare adverse drug reaction to flutamide. PATIENTS AND RESULTS: All 3 patients with advanced prostate carcinoma were treated with oral flutamide at a dose rate of 250 mg 3 times daily. The patients developed clinical signs (jaundice, anorexia, nausea, dark urine etc.) and laboratory liver function test changes (high aminotransferase and bilirubin level), indicative of acute hepatitis, 20-22 weeks after commencing flutamide treatment. The flutamide therapy was immediately discontinued and this resulted in spontaneous remission (clinical and liver function test results returned to normal) during the next 8 weeks. CONCLUSION: Our data clearly suggest that flutamide causes acute hepatitis and that the monitoring of the patients' liver function tests in order to detect these changes as early as possible, is important.