The Possible Role of Prescribing Medications in Contributing to Male-Factor Infertility: Assessment of the FDA Pharmacovigilance Database

The study analyzed the FDA Pharmacovigilance Database to investigate the role of certain medications in contributing to Male-Factor Infertility (MFI). Out of 955 MFI reports, 408 (42.7%) were associated with 20 medications. Drugs like finasteride, testosterone, valproate, diethylstilbestrol, mechlorethamine, verapamil, lovastatin, and nifedipine showed significant levels of disproportionate reporting. Finasteride, often used for alopecia, was associated with 70.9% of total reports and had a Proportional Reporting Ratio (PRR) of 16.04. The study concluded that these drugs may have a possible role in causing MFI, but further research is needed. It also suggested that drug-induced MFI is likely under-reported to regulatory agencies.