Two cases of severe acute hepatitis in patients taking flutamide for m
etastatic prostatic carcinoma are reported. Jaundice and marked increa
se in aminotransferases occurred after 6-8 weeks of treatment. Continu
ation of flutamide administration was associated with the development
of hepatic encephalopathy and a marked prolongation of prothrombin tim
e. One of the patients died of acute liver failure and the other survi
ved after prolonged hospitalization. Rechallenge was not performed bec
ause of the severity of the clinical picture. Liver histology showed e
xtensive hepatic necrosis. These two cases strongly suggest that fluta
mide, in addition to its cholestatic side effects, can induce acute he
patitis potentially with a fulminant and lethal course. (C) Journal of
Hepatology.