Cyproterone Acetate: A Genotoxic Carcinogen?

The document from 2008 reviews the genotoxic and carcinogenic potential of cyproterone acetate, a medication used for conditions like hirsutism, androgenic alopecia, acne, and prostate carcinoma. It was found to cause liver tumors in rats, especially females, due to DNA-damaging intermediates leading to DNA adduct formation, gene mutations, and increased levels of micronuclei. These effects were observed at high doses, and while DNA adducts were also found in human liver cells, epidemiological studies did not show a significant liver cancer risk in patients treated with cyproterone acetate. Regulatory authorities in the European Union concluded that the cancer risk associated with its clinical use appears to be low, and the risk-benefit ratios for authorized indications remain favorable. The document suggests that while there is a potential risk of liver cancer at very high doses, particularly in young people, the current epidemiological data do not indicate an increased risk at recommended dose levels, and the use of cyproterone acetate in authorized indications is considered sufficiently safe.