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

    November 2023 in “ Brain Sciences ”
    Sara Baldini, Ahmed Khattak, Paolo Capogrosso … Nicolò Schifano
    Studysummary This study investigated medications potentially linked to male-factor infertility using the FDA Adverse Event Reporting System and found that finasteride, testosterone, valproate, and other drugs showed significant disproportionate reporting of infertility cases, highlighting a potential under-reporting issue to regulatory bodies.
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    Research cited in this study 12

    1. 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 International Journal of Impotence Research · 2022
    2. Post-Finasteride Syndrome: A Surmountable Challenge for Clinicians Fertility and Sterility · 2020
    3. Sexual Side Effects of 5-Alpha-Reductase Inhibitors Finasteride and Dutasteride: A Comprehensive Review Dermatology Online Journal · 2017
    4. Finasteride Use in the Male Infertility Population: Effects on Semen and Hormone Parameters Fertility and Sterility · 2013
    5. Secondary Infertility Due to Use of Low-Dose Finasteride International Urology and Nephrology · 2012
    6. Morphometric-Stereological and Functional Epididymal Alterations and a Decrease in Fertility in Rats Treated with Finasteride and After a 30-Day Post-Treatment Recovery Period Fertility and Sterility · 2012
    7. The 5 Alpha-Reductase Isozyme Family: A Review of Basic Biology and Their Role in Human Diseases Advances in Urology · 2011
    8. Finasteride-Induced Secondary Infertility Associated with Sperm DNA Damage Fertility and Sterility · 2011
    9. Finasteride-Associated Male Infertility Fertility and Sterility · 2010
    10. Propecia-Induced Spermatogenic Failure: A Report of Two Cases Fertility and Sterility · 2007
    11. The Effect of 5α-Reductase Inhibition with Dutasteride and Finasteride on Semen Parameters and Serum Hormones in Healthy Men The Journal of Clinical Endocrinology and Metabolism · 2007
    12. Chronic Treatment with Finasteride Daily Does Not Affect Spermatogenesis or Semen Production in Young Men The Journal of Urology · 1999