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

    October 2021 in “ International Journal of Andrology ”
    Michael S. Irwig
    Studysummary This paper reports on the controversy surrounding post-finasteride syndrome and questions Merck and the FDA's handling of associated sexual side effects. Despite significant adverse event reports, both entities failed to conduct further studies or enhance patient safety warnings about finasteride's long-term effects.
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    Research cited in this study 6

    1. Post-Finasteride Syndrome: A Surmountable Challenge for Clinicians Fertility and Sterility · 2020
    2. Sexual Dysfunction in Subjects Treated with Inhibitors of 5α-Reductase for Benign Prostatic Hyperplasia: A Comprehensive Review and Meta-Analysis International Journal of Andrology · 2017
    3. An Observational Retrospective Evaluation of 79 Young Men with Long-Term Adverse Effects After Use of Finasteride Against Androgenetic Alopecia International Journal of Andrology · 2016
    4. Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-Analysis PubMed · 2015
    5. Persistent Sexual Side Effects of Finasteride for Male Pattern Hair Loss The Journal of Sexual Medicine · 2011
    6. Adverse Side Effects of 5α-Reductase Inhibitors Therapy: Persistent Diminished Libido, Erectile Dysfunction, and Depression in a Subset of Patients The Journal of Sexual Medicine · 2010

    Related research 9

    1. Finasteride and Erectile Dysfunction in Patients with Benign Prostatic Hyperplasia or Male Androgenetic Alopecia The World Journal of Men's Health · 2018
    2. Post-Finasteride Syndrome and Post-SSRI Sexual Dysfunction: Two Sides of the Same Coin? Endocrine · 2018
    3. Post-Finasteride Adverse Effects in Male Androgenic Alopecia: A Case Report of Vitiligo Skin Pharmacology and Physiology · 2017
    4. Sexual Adverse Effects of Finasteride 1mg for Treatment of Androgenic Alopecia in Men Scripta Scientifica Vox Studentium · 2017
    5. Oral Finasteride Presents With Sexual-Unrelated Withdrawal in Long-Term Treated Androgenic Alopecia in Men PubMed · 2015
    6. Persistent Sexual Side Effects of Finasteride: Could They Be Permanent? The Journal of Sexual Medicine · 2012
    7. Adverse Side Effects of 5α-Reductase Inhibitors Therapy: Persistent Diminished Libido, Erectile Dysfunction, and Depression in a Subset of Patients The Journal of Sexual Medicine · 2010
    8. By The Way, Doctor: Finasteride Has Been Prescribed For My BPH. I Think That The Most Frequent Side Effect Is Erectile Dysfunction Or Loss Of Sexual Desire. Would Levitra Or A Similar Drug (Like Viagra Or Cialis) Overcome The Side Effects Of Finasteride? PubMed · 2009
    9. Evaluation of Sexual Function in Subjects Taking Finasteride for the Treatment of Androgenetic Alopecia Journal of The European Academy of Dermatology and Venereology · 2001