Assessing finasteride-associated sexual dysfunction using the FAERS database.

Area of Science:

• Pharmacovigilance and drug safety research.
• Analysis of adverse event reporting systems.
• Clinical trial data comparison.

Background:

• Postmarketing surveillance indicates finasteride may cause sexual dysfunction.
• Clinical trials reported a low incidence, leaving the true risk unknown.

Purpose of the Study:

• To assess if finasteride increases sexual dysfunction risk compared to other drugs.
• Utilized the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

Main Methods:

• Employed a case by non-case disproportionality analysis.
• Calculated the reporting odds ratio (ROR) with 95% confidence intervals (CI).
• Confirmed findings using the National Ambulatory Medical Care Survey (NAMCS).

Main Results:

• Significant disproportionality in sexual dysfunction reports associated with finasteride use.
• Elevated RORs observed for finasteride in hair loss (138.17) and benign prostatic hyperplasia (93.88).
• Overall ROR for any indication was 173.18; strongest risk noted in the 31-45 age group.

Conclusions:

• Finasteride use is associated with a notable increase in sexual dysfunction reports.
• Finasteride is considered a primary suspect for these adverse events.
• The findings highlight potential safety concerns requiring further investigation.