Suicidality Risks Associated with Finasteride, a 5-Alpha Reductase Inhibitor: An Evaluation of Real-World Data from...

Area of Science:

• Pharmacovigilance and Drug Safety
• Psychiatric Epidemiology
• Dermatology and Urology

Background:

• Finasteride is prescribed for androgenetic alopecia and benign prostatic hyperplasia.
• Concerns exist regarding finasteride's potential psychiatric side effects, including suicidality.
• This study investigates safety signals related to finasteride using FDA Adverse Event Reporting System (FAERS) data.

Purpose of the Study:

• To analyze FAERS data for finasteride-related adverse events from 2015 to 2024.
• To identify and quantify potential safety signals, particularly for suicidality.
• To assess trends in psychiatric side effects associated with finasteride use.

Main Methods:

• Extracted adverse event reports from FAERS database (2015-2024).
• Quantified disproportionality using Bayesian analysis metrics: EBGM, IC, ROR, and PRR.
• Focused analysis on suicidality-related events and serious outcomes.

Main Results:

• The study population was predominantly male (87%), with 43% aged 18-40, mostly using finasteride for hair loss.
• Suicidality safety signals showed an upward trend from 2019, peaking in 2022 and 2024.
• Serious outcomes included disability (18.7%), life-threatening events (12.9%), and death (7.5%).

Conclusions:

• An increasing trend in suicidality safety signals among young male finasteride users since 2019 highlights emerging risks.
• Robust pharmacovigilance is essential for monitoring finasteride's psychiatric effects.
• Collaborative efforts and clear patient guidance are needed to mitigate risks and ensure safety.