US Food and Drug Administration Warning Regarding Finasteride and Suicidal Ideation: What Should Urologists Know?

Haidar Al Saffar; Jennifer Xu; Jonathan S O'Brien; Brian D Kelly; Declan G Murphy; Nathan Lawrentschuk

doi:10.1016/j.euros.2023.04.009

US Food and Drug Administration Warning Regarding Finasteride and Suicidal Ideation: What Should Urologists Know?

Eur Urol Open Sci. 2023 Apr 29:52:4-6. doi: 10.1016/j.euros.2023.04.009. eCollection 2023 Jun.

Authors

Haidar Al Saffar^{1

2}, Jennifer Xu¹, Jonathan S O'Brien^{1

3}, Brian D Kelly^{1

4}, Declan G Murphy^{1

3}, Nathan Lawrentschuk^{1

3

5

6

7}

Affiliations

¹ Department of Genitourinary Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, Australia.
² Urology Department, St. Vincent's Hospital, Fitzroy, Australia.
³ Sir Peter MacCallum Department of Surgical Oncology, The University of Melbourne, Melbourne, Australia.
⁴ Department of Urology, Eastern Health, Box Hill, Australia.
⁵ EJ Whitten Prostate Cancer Research Centre, Epworth Healthcare, Melbourne, Australia.
⁶ Department of Surgery (Urology), Epworth Hospital Richmond, Richmond, Australia.
⁷ Department of Urology, Royal Melbourne Hospital, Parkville, Australia.

Abstract

Finasteride competitively inhibits 5α-reductase (5-AR) isoenzymes, which blocks dihydrotestosterone (DHT) production, thereby reducing DHT. Finasteride is used in the management of benign prostatic hyperplasia (BPH) and androgenic alopecia. Amid patient reports of suicidal ideation (SI), the Post Finasteride Syndrome advocacy group has petitioned for either a stop to selling of the drug or advertisement of stronger warnings. The US Food and Drug Administration recently added SI to the adverse effects listed for finasteride. Here we provide a brief but comprehensive review of the literature on the psychological side effects of 5-AR inhibitors (5-ARIs) to provide an opinion to help in guiding treating urologists. Most of the current evidence, obtained from the literature on dermatology, suggests that 5-ARI users experience a higher rate of depressive symptoms. However, given the lack of comprehensive randomised studies, the causal link between finasteride and SI remains unclear. Urologists prescribing 5-ARIs should be aware of the recent addition of suicide and SI risk to the list of side effects. A mental health screen should be performed and appropriate resources provided to patients commencing treatment. Furthermore, a review should be arranged with the general practitioner to assess new-onset mental health or SI symptoms.

Patient summary: We provide recommendations for urologists who prescribe finasteride for the treatment of benign prostate enlargement. Urologists should be aware of the recent addition of suicidal ideation to the list of side effects for this drug. Finasteride prescription should be continued; however, we recommend a detailed medical history to screen for prior mental health and personality disorders, with discontinuation of the medication in patients with new onset of depression or suicidal symptoms. Close liaison with the patient's general practitioner is vital for management of depressive or suicidal symptoms.

Keywords: Adverse effect; Adverse event reporting system; Androgenic alopecia; Benign prostatic hyperplasia; Dihydrotestosterone; Finasteride; Food and Drug Administration; Lower urinary tract symptoms.