Are Finasteride-Related Penile Curvature/Peyronie’s Disease Adverse Event Reports Worthy of Further Clinical Investigation? Disproportionality Analysis Based on Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Pharmacovigilance Databases

The study analyzed adverse drug reactions from the FDA and EMA databases to investigate a potential link between finasteride and Peyronie’s disease (PD). Out of 860 reports of "penile curvature" and/or PD in the FDA database, 214 (24.9%) were linked to finasteride, primarily associated with androgenetic alopecia. The Proportional Reporting Ratios (PRRs) were 6.6 and 11.8 in the FDA and EMA databases, respectively, indicating strong signals of disproportionality. Despite these findings, the study acknowledges limitations and biases in spontaneous reporting and calls for further clinical studies to confirm any causal relationship.