Safety Concerns of Paternal Drug Exposure on Fertility, Pregnancy, and Offspring: An Analysis Based on the FDA Adverse Event Reporting System

This study analyzed data from the FDA adverse event reporting system (2010–2022) to assess the impact of paternal drug exposure on fertility, pregnancy outcomes, and offspring health. Out of 16,180,533 reports, 3,210 were related to paternal exposure, identifying 115 signals concerning reproductive health. Significant findings include diazepam's association with small for dates babies, finasteride with cryptorchidism, and frequent spontaneous abortion signals linked to biologics for immune inflammation. Immunosuppressive drugs were associated with congenital anomalies, notably belatacept with skeletal dysplasia and tacrolimus with talipes. Anti-tumor agents like etoposide and cisplatin showed high reproductive toxicity, particularly trisomy 13. The study highlights the need for clinical attention to these drug associations.