Flutamide

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Flutamide is a nonsteroidal antiandrogen. It has been administered to transgender women in a number of studies/publications.[1][2][3] It is used for the treatment of hirsutism at dosages ranging from 62.5 mg/day to 500 mg/day and both alone and in combination with oral contraceptives.[4] The overall quality of the evidence for hirsutism is regarded as moderate.[5] Flutamide may be more effective than other antiandrogens like spironolactone, cyproterone acetate, and finasteride for this indication.[5]

Flutamide has a relatively high risk of elevated liver enzymes and hepatotoxicity and has been associated with many cases of severe hepatotoxicity, including deaths.[6][7][8][9][10] The risk is substantially higher than with other nonsteroidal antiandrogens like bicalutamide and nilutamide.[9] Because of its high risk of hepatotoxicity, flutamide has been recommended against for the treatment of androgen-dependent conditions like acne and hirsutism in cisgender women.[7][5][11]

Low or ultra-low doses of flutamide have been reported to lack hepatotoxicity.[12][13][14][15] However, other studies have had very different findings.[16][17][18] In addition, many case reports of severe hepatotoxicity at low or ultra-low doses exist, including deaths.[19][8][20][21]

References

  1. Giusti, M., Falivene, M. R., Carraro, A., Cuttica, C. M., Valenti, S., & Giordano, G. (1995). The effect of non-steroidal antiandrogen flutamide on luteinizing hormone pulsatile secretion in male-to-female transsexual subjects. Journal of endocrinological investigation, 18(6), 420-426.
  2. Falivene, M. R., Cuttica, C. M., Valenti, S., & Guido, R. (1995). Androgen receptor blockade with flutamide increases GH secretion in male-to-female transsexuals. Journal of Endocrinological Investigation, 18, 56-56.
  3. Valenti, S., Fazzuoli, L., & Giusti, M. (2003). Circulating nitric oxide levels increase after anti-androgen treatment in male-to-female transsexuals. Journal of endocrinological investigation, 26(6), 522-526.
  4. Generali, J. A., & Cada, D. J. (2014). Flutamide: hirsutism in women. Hospital pharmacy, 49(6), 517.
  5. 5.0 5.1 5.2 Somani, N., & Turvy, D. (2014). Hirsutism: an evidence-based treatment update. American journal of clinical dermatology, 15(3), 247-266.
  6. Wysowski, D. K., & Fourcroy, J. L. (1996). Flutamide hepatotoxicity. The Journal of urology, 155(1), 209-212.
  7. 7.0 7.1 Giorgetti, R., di Muzio, M., Giorgetti, A., Girolami, D., Borgia, L., & Tagliabracci, A. (2017). Flutamide-induced hepatotoxicity: ethical and scientific issues. Eur Rev Med Pharmacol Sci, 21(1 Suppl), 69-77.
  8. 8.0 8.1 Brahm, J., Brahm, M., Segovia, R., Latorre, R., Zapata, R., Poniachik, J., ... & Contreras, L. (2011). Acute and fulminant hepatitis induced by flutamide: case series report and review of the literature. Annals of hepatology, 10(1), 93-98.
  9. 9.0 9.1 Thole, Z., Manso, G., Salgueiro, E., Revuelta, P., & Hidalgo, A. (2004). Hepatotoxicity induced by antiandrogens: a review of the literature. Urologia internationalis, 73(4), 289-295.
  10. García, C. M., Andrade, R. J., Lucena, M. I., Sánchez, M. H., Fernandez, M. C., Ferrer, T., ... & Montero, J. L. (2001). Flutamide-induced hepatotoxicity: report of a case series. Revista española de enfermedades digestivas: organo oficial de la Sociedad Española de Patología Digestiva, 93(7), 423-432.
  11. Schmidt, T. H., & Shinkai, K. (2015). Evidence-based approach to cutaneous hyperandrogenism in women. Journal of the American Academy of Dermatology, 73(4), 672-690.
  12. Ibanez, L., Jaramillo, A., Ferrer, A., & de Zegher, F. (2005). Absence of hepatotoxicity after long-term, low-dose flutamide in hyperandrogenic girls and young women. Human Reproduction, 20(7), 1833-1836.
  13. Legro, R. S. (2006). Long-term, low-dose flutamide does not cause hepatotoxicity in hyperandrogenic women. Nature Clinical Practice Endocrinology & Metabolism, 2(4), 188-189.
  14. Calaf, J., Lopez, E., Millet, A., Alcaniz, J., Fortuny, A., Vidal, O., ... & Espinos, J. J. (2007). Long-term efficacy and tolerability of flutamide combined with oral contraception in moderate to severe hirsutism: a 12-month, double-blind, parallel clinical trial. The Journal of Clinical Endocrinology & Metabolism, 92(9), 3446-3452.
  15. Dikensoy, E., Balat, O., Pence, S., Akcali, C., & Cicek, H. (2009). The risk of hepatotoxicity during long-term and low-dose flutamide treatment in hirsutism. Archives of gynecology and obstetrics, 279(3), 321-327.
  16. Paradisi, R., Fabbri, R., Porcu, E., Battaglia, C., Seracchioli, R., & Venturoli, S. (2011). Retrospective, observational study on the effects and tolerability of flutamide in a large population of patients with acne and seborrhea over a 15-year period. Gynecological Endocrinology, 27(10), 823-829.
  17. Bruni, V., Peruzzi, E., Dei, M., Nannini, S., Seravalli, V., Sisti, G., & Fambrini, M. (2012). Hepatotoxicity with low-and ultralow-dose flutamide: a surveillance study on 203 hyperandrogenic young females. Fertility and sterility, 98(4), 1047-1052.
  18. Castelo-Branco, C., Hernández-Angeles, C., Alvarez-Olivares, L., & Balasch, J. (2016). Long-term satisfaction and tolerability with low-dose flutamide: a 20-year surveillance study on 120 hyperandrogenic women. Gynecological Endocrinology, 32(9), 723-727.
  19. Castelo-Branco, C., & Del Pino, M. (2009). Hepatotoxicity during low-dose flutamide treatment for hirsutism. Gynecological Endocrinology, 25(7), 419-422.
  20. Osculati, A., & Castiglioni, C. (2006). Fatal liver complications with flutamide. The Lancet, 367(9517), 1140-1141.
  21. Amorim, M. D. F. D. D., Amorim, W. P. D. D., Duques, P., Amorim, P. D. D., & Vasconcelos, J. R. D. (2005). Flutamide-induced hepatotoxicity during treatment of acne: a case report. Anais Brasileiros de Dermatologia, 80(4), 381-384.