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The alopecia treatment finasteride (Propecia) was tied to suicidality in male users, a new study found.

Looking at over 3,200 users, there were 2,926 reports of psychological adverse events -- defined as cases of depression and anxiety -- associated with the use of finasteride, reported Quoc-Dien Trinh, MD, of Brigham and Women's Hospital in Boston, and colleagues.

This equated to a more than four times higher chance of experiencing depression and anxiety while using finasteride (reporting odds ratio [ROR] 4.33, 95% CI 4.17-4.49), the group wrote in .

Psychological adverse events associated with finasteride didn't end there, as there were also 356 reports of suicidality, including suicidal ideation, attempted suicides, and completed suicides, among these users.

They found a 63% higher odds of experiencing suicidality (ROR 1.63, 95% CI 1.47-1.81), with a more than four times higher chance of experiencing suicidal ideation (ROR 4.39, 95% CI 3.90-4.95). Looking at attempted and completed suicides separately, there was not a significant association.

Acting as a 5α-reductase inhibitor, safety concerns over oral finasteride have swirled for years after its approval in 1997, particularly stemming from a leading to the addition of depression to the adverse reactions section of . At that point, the label already included several sexual dysfunction-related adverse events, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders.

"There is a plausible biological basis linking finasteride ... with depression and anxiety," the researchers wrote. "Some reports suggest that men with depression have lower levels of the neurosteroid allopregnanolone, which is produced by the 5α-reductase enzyme and has antidepressant and anxiolytic effects."

For this pharmacovigilance case-noncase study, the researchers drew upon data from the World Health Organization's 153-country VigiBase database. Nearly all reports of suicidality, depression, and anxiety were in either American or European users.

Certain users were more likely to experience these adverse mental health effects while on finasteride. A sensitivity analysis determined that patients 45 years of age and younger were more likely to experience suicidality compared with users over the age of 45 (ROR 3.47, 95% CI 2.90-4.15).

Additionally, those prescribed finasteride for the indication of androgenetic alopecia, otherwise known as male or female pattern baldness, had significantly higher chances of suicidality compared with an unknown or ambiguous indication or for the indication of benign prostatic hyperplasia (ROR 2.06, 95% CI 1.81-2.34).

Another part of the sensitivity analysis found that other similar treatment options on the market -- tamsulosin (Flomax) and dutasteride (Avodart) both indicated for benign prostatic hyperplasia or minoxidil (Rogaine) indicated for alopecia areata -- did not have the same safety signals as finasteride

The associations between finasteride and adverse mental health effects were not dose dependent.

Looking at data from 1992-2019, reports of depression, anxiety, and suicidality increased significantly among users after the year 2012 (ROR 2.13, 95% CI 1.91-2.39).

In an , Roger Ho, MD, MPH, of New York University Grossman School of Medicine, pointed out that this uptick in reports in 2012 isn't much of a surprise due to the fact that it came at the same time as the publication of the originally linking suicidality and finasteride, as well as the establishment of , all leading to the for "post-finasteride."

Ho also suggested that these findings "should be considered as exploratory" and be the impetus for future large-scale prospective pharmacoepidemiologic studies specifically designed to assess these outcomes.

"Health care professionals should keep themselves abreast of these potential signals and, accordingly, conduct a full evaluation and a detailed, personalized risk-benefit assessment for patients before each prescription of finasteride," he recommended.

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