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

The study analyzes data from the FDA Adverse Event Reporting System to assess the impact of paternal drug exposure on fertility, pregnancy, and offspring health. It examines 16,180,533 reports, with 3,210 related to paternal exposure, revealing significant risks associated with certain drugs. Notably, biologics for inflammatory diseases, diazepam, and finasteride are linked to adverse reproductive outcomes, while immunosuppressive and antiepileptic drugs show strong signals for congenital anomalies. Chemotherapy drugs may be associated with genetic risks. The study underscores the need for further research and preconception counseling to address these risks, despite limitations such as reporting biases and the absence of maternal data.