Abstract

Finasteride is a 5α-reductase enzyme inhibitor that has been approved for the treatment of male androgenic alopecia since 1997. Over time, it has been considered a safe and well-tolerated drug with rare and reversible side effects. Recently there have been reports of adverse drug-related reactions that persisted for at least three months after discontinuation of this drug, and the term post-finasteride syndrome arose. It includes persistent sexual, neuropsychiatric, and physical symptoms. Studies to date cannot refute or confirm this syndrome as a nosological entity. If it actually exists, it seems to occur in susceptible people, even if exposed to small doses and for short periods, and symptoms may persist for long periods. Based on currently available data, the use of 5α-reductase inhibitors in patients with a history of depression, sexual dysfunction, or infertility should be carefully and individually assessed.

Highlights

  • Finasteride is an inhibitor of the enzyme 5␣-reductase types 1 and 2 --- with greater affinity for type 2 --- that has been approved by the Food and Drug Administration (FDA) in the United States for the treatment of benign prostatic

  • In 2015, post-finasteride syndrome (PFS) was included in the list of Rare and Genetic Diseases of the National Institutes of Health (NIH).[4]

  • Neuroactive steroids comprise steroid hormones synthesized in peripheral glands acting on the central nervous system (CNS), as well as neurosteroids produced in the brain itself.[28]

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Summary

Introduction

Finasteride is an inhibitor of the enzyme 5␣-reductase types 1 and 2 --- with greater affinity for type 2 --- that has been approved by the Food and Drug Administration (FDA) in the United States for the treatment of benign prostatic. Several studies have demonstrated that finasteride is a safe and well-tolerated drug, with rare and reversible side effects such as reduced sexual libido and ejaculatory volume, most commonly observed when prescribed in a daily dose of 5 mg for cases of BPH.[1]. Post-finasteride syndrome (PFS) includes persistent sexual, neuropsychiatric, and physical adverse reactions in patients who used this drug. Regulatory agencies in several countries generated warnings about this drug; in 2012, the FDA demanded changes in the package insert in the United States, including the possibility of persistent side effects.[3] In 2015, PFS was included in the list of Rare and Genetic Diseases of the National Institutes of Health (NIH).[4]. Symptoms of PFS include decrease or complete loss of libido, low or no reaction to sexual stimulation, erectile dysfunction, loss of pleasure or absence of sensation in orgasm, loss of genital sensitivity, decrease in ejaculated volume, poor semen quality and infertility, penis shrinkage, abnormal penis curvature (Peyronie’s disease), testicular pain, testicular reduction, gynecomastia, chronic fatigue, muscle weakness, muscle atrophy and/or pain, muscle spasms, joint pain, dry skin, memory problems, slow thinking, comprehension difficulties, depression (including suicidal thoughts), anxiety disorder, panic attacks, emotional detachment, and insomnia.[5]

Finasteride and sexual adverse effects
Finasteride and infertility
Finasteride and neuropsychiatric adverse effects
Finasteride and metabolic and cardiovascular events
Final considerations
Financial support
Findings
CME Questions
Full Text
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