(SLB-011) The risk of suicidality with the use of 5-Alpha-Reductase Inhibitors: Real-world evidence utilizing the Food and Drug Administration Adverse Event Reporting System (FAERS)

Background: Finasteride and dutasteride are prescribed for treating benign prostatic hyperplasia (BPH) and androgenetic alopecia. Although generally well-tolerated, there are concerns about their potential psychiatric side effects, including depression and suicidality, which can manifest as suicidal thoughts, attempts, or completed suicide.

Objectives: This study aims to assess the safety signals related to suicidality and their magnitude in the adverse event reports, which are linked to finasteride and dutasteride utilizing real-world data.

Methods: This retrospective study comprehensively analyzed the FDA adverse event reporting system (FAERS) database from 2015 to 2024 to identify events related to suicidality associated with the use of finasteride and dutasteride. The preferred term was used to determine the outcome of interest which were reports of suicide-related terms such as complete suicide, suicidal ideation, and suicide attempts. A descriptive analysis was performed on the reported characteristics. Moreover, inferential analyses using both traditional and Bayesian statistical analysis methods were used to identify disproportionate statistics, including the Reporting Odds Ratio (ROR) and the Information Component (IC).

Results: A total of 1,587 suicidality-related safety signals were identified during the study period, amounting to 11.42% of the total signals (n=13,897). The reports were obtained from several countries worldwide, with 34.28% originating from Great Britain, followed by 24.07% from the United States. Of these reports, 38.75% pertained to patients between 18-40 years, followed by 8.7% of those between 40-60 years of age. Interestingly, more than half of the reporters were patients, followed by physicians at 17.71%. Key outcomes of these adverse event reports (AERs) were identified, with over half of the AERs resulting in serious events (51.73%). The disproportionality statistics revealed an increased trend from 2015 that has reached its peak in 2021, with a slight fluctuation since then. Overall, the signal of suicidality with the use of these medications was as low as an ROR of 6.09 (95% CI 5.76-8.27) and IC of 2.66 in 2015, and the highest was in 2021 with an ROR of 26.09 (95% CI 22.17-30.70) and IC of 4.35.

Conclusions: There is a significant number of suicidality-related signals with the use of finasteride and dutasteride, necessitating further risk evaluation and management. Close monitoring of such events must be considered to prevent and/or to reduce the severity and persistence of these events. Although the study has shown clearly the presence of safety signals, , future research is required specifically to examine the relationship between the study medications and suicidality.