(719) Signal Detection of Depression and Suicidality With the 5-Alpha Reductase Inhibitors: Evidence from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) Database

Introduction Finasteride and dutasteride are 5-alpha reductase inhibitors (5-ARIs) typically prescribed for both benign prostatic hyperplasia (BPH) and androgenetic alopecia. These agents have recently raised concerns due to their possible association with psychiatric adverse drug reactions (ADRs). The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database was queried to investigate on this issue. Objective none Methods The ADRs listing 5-ARIs as suspected agents in the FAERS database were analysed, regardless of the dosages and indication for prescription. ADRs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms. Psychiatric ADRs were categorized into depressive-, suicidality-, anxiety-, and libido-related groups. Duplicate entries were excluded. Reporting Odds Ratios (RORs) and their 95% confidence intervals (CIs) were calculated to identify any disproportional reporting signal for psychiatric ADRs relating to 5-ARIs. Results 27,578 ADRs were reported for finasteride, including 8,087 (29.3%) psychiatric ADRs. When finasteride was the sole suspected drug 6,754 psychiatric ADRs were identified, of which 5,170 (76.6%) were serious and 1,584 (23.4%) were non-serious. After deduplication, 4,132 serious cases were analysed, most commonly depressive disorders (n = 2,252), anxiety (n = 1,524), suicidality (n = 1,109), and libido disorders (n = 2,122). For dutasteride, 9,161 total ADRs were reported, of which 1,219 (13.3%) were psychiatric, with 333 serious cases after deduplication. The most frequent events included depressive symptoms (n = 55), libido disorders (n = 57), anxiety (n = 27), and suicidality (n =24). Disproportionality analysis identified more disproportional reporting for finasteride vs. dutasteride. Conclusions Although psychiatric ADRs seem to be more disproportionally reported with finasteride vs. with dutasteride, these psychiatric reports are prevalent for both of the molecules. Any actual causal relationship between these psychiatric issues and the 5-ARIs and their possible biological plausibility cannot be conclusively infered based on this analysis. Continued post-marketing surveillance and prospective studies are needed to better clarify the neuropsychiatric safety profile of the 5-ARIs. Disclosure No