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

October 2021 in “ International Journal of Andrology ”

Michael S. Irwig

finasteride androgenetic alopecia post-finasteride syndrome erectile dysfunction male infertility depressive disorders FDA Adverse Event Reporting System Propecia

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.

Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer

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research Post-Finasteride Syndrome: A Surmountable Challenge for Clinicians

30 citations , January 2020 in “Fertility and Sterility”

This review discusses the evidence for post-finasteride syndrome as a condition potentially induced by finasteride and dutasteride, associating them with sexual dysfunction, depression, anxiety, and suicidal ideation in a subset of men, and reports no new clinical results.

Sexual Dysfunction in Subjects Treated with Inhibitors of 5α-Reductase for Benign Prostatic Hyperplasia: A Comprehensive Review and Meta-Analysis

research Sexual Dysfunction in Subjects Treated with Inhibitors of 5α-Reductase for Benign Prostatic Hyperplasia: A Comprehensive Review and Meta-Analysis

66 citations , April 2017 in “International Journal of Andrology”

This study found that 5α-reductase inhibitors significantly increase the risk of erectile dysfunction and hypoactive sexual desire in men with benign prostatic hyperplasia, compared to placebo.

An Observational Retrospective Evaluation of 79 Young Men with Long-Term Adverse Effects After Use of Finasteride Against Androgenetic Alopecia

research An Observational Retrospective Evaluation of 79 Young Men with Long-Term Adverse Effects After Use of Finasteride Against Androgenetic Alopecia

43 citations , January 2016 in “International Journal of Andrology”

This study found that men experiencing long-term symptoms after finasteride use for androgenetic alopecia frequently reported loss of penis sensitivity and anhedonia, among other effects, indicating potential post-finasteride syndrome.

research Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-Analysis

44 citations , April 2015 in “PubMed”

This study reports that clinical trials of finasteride for androgenic alopecia provide insufficient and systematically biased safety data, with most participants unrepresentative of those in pivotal trials that led to FDA approval.

research Persistent Sexual Side Effects of Finasteride for Male Pattern Hair Loss

185 citations , March 2011 in “The Journal of Sexual Medicine”

This study found that 94% of healthy men reported low libido and 92% reported erectile dysfunction as persistent sexual side effects after using finasteride for male pattern hair loss, with these effects lasting on average 40 months post-discontinuation.

Adverse Side Effects of 5α-Reductase Inhibitors Therapy: Persistent Diminished Libido, Erectile Dysfunction, and Depression in a Subset of Patients

research Adverse Side Effects of 5α-Reductase Inhibitors Therapy: Persistent Diminished Libido, Erectile Dysfunction, and Depression in a Subset of Patients

223 citations , December 2010 in “The Journal of Sexual Medicine”

This review discusses persistent adverse effects of 5α‐reductase inhibitors, like diminished libido and erectile dysfunction, in some patients and highlights the need for patient discussions before therapy, especially for androgenetic alopecia.