Hepatotoxicity with Low- and Ultralow-Dose Flutamide: A Surveillance Study on 203 Hyperandrogenic Young Females

    July 2012 in “ Fertility and Sterility
    Vincenzina Bruni, Elena Peruzzi, Metella Dei, Sara Nannini, Viola Seravalli, Giovanni Sisti, Massimiliano Fambrini
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    TLDR Low and ultralow doses of flutamide can cause liver damage in young women with high androgen levels, regardless of dose or birth control use, with higher risk for those with higher BMI and liver enzyme levels before treatment.
    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.
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