Hepatotoxicity with low- and ultralow-dose flutamide: a surveillance study on 203 hyperandrogenic young females

The study monitored 203 young females with hyperandrogenism taking low (62.5 mg/daily) and ultralow (125 mg/daily) doses of flutamide over a 10-year period to assess liver function. Hepatotoxicity, indicated by elevated levels of AST/ALT, was observed in 19 patients (9.4%), with no significant difference between dosage groups or with the use of oral contraceptives. The median time to hepatotoxicity was 12 weeks, and a higher risk was associated with higher pretreatment BMI and baseline AST/ALT levels. The study also noted that hepatotoxicity was not solely dose-dependent and that genetic factors, including polymorphisms in CYP1A2 and AADAC enzymes, might influence individual susceptibility. Despite flutamide's importance in treating hyperandrogenism, the study emphasized that hepatotoxicity is a potential risk even at low doses and that there is no current method to predict which patients will be affected, highlighting the need for larger studies to identify risk patterns.