Drugs Associated the Most with Male-Factor Infertility: Assessment of the 2010-2020 Food and Drug Administration Pharmacovigilance Database

    August 2021
    Nicolò Schifano, Paolo Capogrosso, Luca Boeri, Stefania Chiappini, Edoardo Pozzi, Federico Belladelli, Omer Onur Cakir, Matthew Rewhorn, Fabio Castiglione, Hussain M. Alnajjar, Asif Muneer, Federico Dehò, Fabrizio Schifano, Francesco Montorsi, Andrea Salonia
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    TLDR Finasteride and testosterone are the drugs most linked to male infertility, but many other potential drugs may be under-reported.
    The study analyzed the Food and Drug Administration (FDA) Adverse Event Reporting System database from 2010-2020 to identify drugs most associated with male-factor infertility (MFI). Out of 492 MFI reports, 199 (40.4%) were linked to 16 medications with more than 5 reports each. However, only finasteride and testosterone showed significant levels of disproportionate reporting, with Proportional Reporting Ratios (PRRs) of 31.30 and 8.29, respectively. The study concluded that while several medications were associated with MFI reports, many well-known agents were not represented, suggesting under-reporting of drug-induced MFI to regulatory agencies. The researchers recommend that reproductive urologists increase efforts in detecting and reporting these adverse drug reactions.
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