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Flutamide-induced hepatotoxicity: ethical and scientific issues
R Giorgetti1, M di Muzio, A Giorgetti
1Section of Legal Medicine, Università Politecnica delle Marche, Ancona, Italy. r.giorgetti@univpm.it.
European Review for Medical and Pharmacological Sciences
|April 6, 2017
Summary
Flutamide (FLU), used off-label for women
Area of Science:
- Pharmacology
- Hepatology
- Reproductive Medicine
Background:
- Flutamide (FLU) is a non-steroidal antiandrogen approved for advanced prostate cancer.
- It is frequently prescribed off-label for women with polycystic ovary syndrome (PCOS)-related hirsutism and acne.
- Adverse event incidence may be higher in women than in men.
Purpose of the Study:
- To investigate the adverse effects of Flutamide (FLU) on hepatic and reproductive function in women.
- To review the scientific literature on Flutamide's (FLU) safety profile in female patients.
- To assess the ethical and legal implications of off-label Flutamide (FLU) use in women.
Main Methods:
- A comprehensive literature search was performed in major scientific databases.
- Studies focused on unintended Flutamide (FLU) effects on liver and reproductive health.
- Both human and animal studies were included, with reference lists of selected papers also reviewed.
Main Results:
- Twenty-three human studies (case reports, retrospective, prospective, surveillance, observational) were analyzed.
- Nine animal studies were also evaluated.
- Evidence indicates Flutamide (FLU) is associated with specific hepatotoxic profiles in females.
Conclusions:
- Flutamide (FLU) poses risks for hepatotoxicity in women.
- Off-label prescription of Flutamide (FLU) for women is ethically questionable and potentially unlawful.
- Prescribers may face liability without adequate safeguards for off-label Flutamide (FLU) use in female patients.
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