How Routine Pharmacovigilance Failed to Identify Finasteride’s Persistent Sexual Side Effects

    October 2021 in “ International Journal of Andrology ”
    Michael S. Irwig
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    TLDR Finasteride, a hair loss drug, has unaddressed sexual side effects due to the manufacturer's inadequate safety measures and lack of additional studies.
    The document discusses the controversy surrounding the persistent sexual side effects of finasteride, a drug used for androgenetic alopecia. Despite warnings from regulatory agencies and published articles on the adverse effects, the existence of post-finasteride syndrome remains disputed. In 2021, internal documents from Merck, the manufacturer of finasteride, revealed that the company had identified potential risks such as persistent erectile dysfunction, male infertility, and depressive disorders. However, instead of conducting further studies to investigate these risks, Merck's Risk Management Safety Team opted for routine pharmacovigilance. The document criticizes this decision, arguing that it failed to provide adequate information on the drug's side effects. The document also criticizes the FDA for not advising or requiring Merck to conduct additional safety studies. As of June 2021, the FDA's Adverse Event Reporting System recorded 10,295 serious adverse events for finasteride, with the most common reactions related to sexual dysfunction.
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