French drug regulator ANSM, meanwhile, turned up 2 new suicides after the EMA ruled in May that the benefits of 5-ARIs outweigh the risks
Oct. 13, 2025
Flying in the face of cowardly stereotypes, France isn’t retreating so much as one centimeter on the finasteride front.
Instead, the nation where at least 26,000 men take the embattled drug for hair loss is poking holes in long-standing presumptions often used to question the mere existence of PFS.
Apples and oranges
Last month, researchers at the Regional Pharmacovigilance Center in Limoges published a study analyzing cases of depressive disorders among finasteride patients not also suffering from loss of libido or sexual dysfunction.
In all, Marie-Laure Laroche, MD, and Hélène Géniaux, PharmD, turned up 40 such incidents, with a median age of 31, in France’s National Pharmacovigilance Database (BNPV). Forty percent of those cases included suicidality, while only 22.5% had any pre-finasteride history of anxiety, depression or suicidality.
“Contrary to hypotheses that depression might result from finasteride-induced sexual dysfunction, our findings support the possibility of a direct effect of finasteride on the brain,” writes Dr. Laroche. “One proposed mechanism involves the disruption of neurosteroids such as dihydrotestosterone (DHT) and allopregnanolone, both known to exert [anxiety-reducing] and antidepressant effects.”
Additionally, she notes that in an overwhelming majority of the psychiatric cases (92.5%), the adverse drug reactions (ADRs) occurred during treatment.
“By focusing on isolated serious depressive disorders, our study differs from many publications that examine psychiatric effects only in the context of sexual dysfunction or ‘post-finasteride syndrome,’” adds Dr. Laroche.
“The high proportion of suicidality (35% with suicidal thoughts and 5% with suicide attempts) underscores the severity of these symptoms… These findings stress the importance of thorough psychiatric screening and suicide risk assessment from the initial prescription onward.”
Titled Isolated depressive disorders and suicidality with finasteride use for androgenetic alopecia: a call for enhanced vigilance, the retrospective descriptive analysis was published Sept. 18 in Therapies, the official publication of the French Society of Pharmacology and Therapeutics.
“For years, certain health providers, dispensers and researchers—parties with either a direct or indirect financial interest in finasteride—have bent over backwards trying to dismiss PFS as a psychosomatic phenomenon among young men taking the drug to combat alopecia,” says PFS Foundation President Philip Recchia, who had no involvement in Dr. Laroche’s research.
“They argue that these patients are often prone to depression pre-finasteride and become even more depressed by their hair loss, which in turn leads to sexual dysfunction and, in some cases, suicidality. This new study, however, presents strong evidence that young men taking finasteride 1 mg can develop severe depressive symptoms independent of loss of libido and pre-existing psychiatric conditions.”
(Background-info alert)
The Regional Pharmacovigilance Center in Limoges is one of 31 such facilities located throughout France, all of which are overseen by the nation’s drug regulator ANSM, and all of which collect ADRs and related data for BNPV.
That data, in turn, is aggregated in Eudravigilance, a database of ADRs reported by all 27 European Union nations, and run by the European Medicines Agency (EMA). Again in turn, all Eudravigilance data is aggregated in VigiBase, a database of ADRs reported by all 194 World Health Organization (WHO) member nations, and overseen by the WHO.
A retrospective descriptive analysis, meanwhile, is a study that utilizes ADR data collected in such databases to identify trends, frequencies, and patterns of safety issues associated with a drug.
As for finasteride usage in France, according to the most recently available data from ANSM, about 26,000 units of finasteride 1 mg are sold monthly, with each unit equating to one month’s supply.
Intense dissent
In May, the EMA released the results of its investigation into reported links between finasteride therapy and suicidality, which was launched in October 2024.
The agency concluded that finasteride “can cause depressed mood, depression or suicidal thoughts. In some patients taking 1 mg finasteride tablets, problems with sexual function…may contribute to mood changes, including suicidal thoughts.”
The investigation turned up a total of 313 cases of suicidal ideation probably or possibly stemming from finasteride use, and 13 probably or possibly from dutasteride, a fellow 5-alpha reductase inhibitor (5-ARI). The majority of those cases involved patients taking finasteride 1 mg for hair loss.
The EMA nonetheless opted not to suspend or remove 5-ARIs from the market, concluding “the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses,” and adding that “A warning about mood changes, including depression, depressed mood and suicidal ideation, is already included in the product information for finasteride medicines.”
Two weeks later, ANSM issued its position on the EMA’s recommendations, which read, in part:
The measures proposed…to reduce the risk of suicidal ideation with finasteride 1 mg (update of product information, introduction of a patient-alert card, and dissemination of a letter to healthcare professionals) appear to be insufficient. This situation is all the more alarming because, despite our implementation over the years of multiple risk-reduction measures …serious cases of psychiatric disorders and sexual dysfunction continue to be reported… In this context, ANSM considers that no action proposed by the [EMA] can satisfactorily reduce these risks.
And just three weeks ago, ANSM issued a new statement on the finasteride-safety issue, noting with regard to its new retrospective descriptive analysis:
These data reinforce our conviction that the benefit/risk ratio of 1 mg finasteride in androgenetic alopecia is unfavorable. We believe that the measures at the European level do not sufficiently reduce the risk of suicidal ideation. Because despite actions and information designed to monitor of adverse reactions that we have been conducting since 2019, severe cases of psychiatric disorders and sexual disorders continue to be reported to us, especially with the 1 mg finasteride used in androgenetic alopecia…
Since May 31, 2024… two more suicides have been reported to BNPV in people treated for alopecia with finasteride. We are therefore continuing our actions at the national level to further strengthen our information on this drug used by young, healthy men.
All roads lead to Romain
In the early hours of June 7, 2016, 25-year-old Romain Mathieu, who had done so well at the prestigious ESPC Business School in Paris that the London branch of Deutsche Bank offered him a job, died by suicide in a forest not far from his family’s home outside the French capital.
After struggling with many persistent side effects of PFS for more than five years, he could live no longer, and declared that dying was not a choice. And so he signed his farewell letter “Romain Mathieu, victim of Merck and Propecia.”
Within less than a year, Romain’s outraged mother, Sylviane Millon-Mathieu, and his sister, Marion Mathieu, founded the advocacy organization Aide aux Victimes du Finastéride (AVFIN). Its two core missions are: (1) providing resources and support to French patients suffering from PFS, and (2) to collaborating with various health authorities, including ANSM, to ensure stricter control of finasteride and more comprehensive public information on its many potential dangers.
Since 2017, AVFIN has consistently fulfilled these missions, first by encouraging ANSM to launch the world’s most vigilant PFS prevention program, which included the publication of public-awareness leaflets, patient information sheets, and adverse-reaction reporting aids. Shortly thereafter, ANSM mandated the inclusion of a red-box warning, alerting consumers and healthcare professionals that a prescription drug carries significant risks of adverse effects, on all finasteride 1 mg products. To date, France remains the only country to have implemented such a warning.
Last year, AVFIN also led the campaign within ANSM to urge the EMA to launch its finasteride-safety investigation. Ditto rejecting its business-as-usual stance on the drug, despite finding that it was linked to hundreds of suicidality cases.
“As more and more families worldwide endure the horrors of a loved one killing himself after taking finasteride—and want to help put an end to this epidemic—we hope they’ll look to Sylviane for inspiration,” says Recchia.
“That process begins with reporting the death to your local drug-regulatory authority.”
If you know someone who took his own life and you suspect the cause was finasteride, please email ColdCase@pfsfoundation.org.
Finasteride was originally developed by Merck & Co., Inc., and first approved by the US Food and Drug Administration in 1993 as Proscar (5 mg, for enlarged prostate), and again in 1997, as Propecia (1 mg, for hair loss).
In June 2021, Merck spun off its Organon subsidiary as an independent public company (NYSE: OGN). Founded in the Netherlands in 1923, Organon bills itself as a “global health care company dedicated to making a world of difference for women, their families and the communities they care for.”
Among the Merck products Organon acquired in the deal were Proscar and Propecia. To report adverse events for either finasteride product, call the Organon Service Center at (844)674-3200, or email Service_Center@Organon.com.
Anyone living in the US who suffers from PFS should also report his or her symptoms to the US FDA. Anyone living outside the US who suffers from PFS should report his or her symptoms to the US FDA as well as to his or her local DRA, as directed on our Report Your Side Effects page.
If you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: social@pfsfoundation.org
Thank you.