Despite enacting world’s strictest finasteride-safety measures three years ago, ‘serious cases of psychiatric disorders and sexual dysfunction continue to be reported,’ reasons ANSM
May 23, 2025
Dear Friends:
Looks like a “Frexit” is afoot in Europe, at least when it comes to helping prevent finasteride patients from taking their own lives.
Yesterday, French drug-regulatory authority ANSM issued a position on recommendations handed down by the European Medicine Agency (EMA) following its investigation into the causal relationship between 5-alpha reductase inhibitors (5-ARIs) and suicidality.
“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,” the agency wrote.
“This situation is all the more alarming because, despite our implementation over the years of multiple risk- reduction measures, namely communications on our website and by mail, a patient information sheet, and a boxed warning and QR code on the outer packaging, serious cases of psychiatric disorders and sexual dysfunction continue to be reported,” ANSM continued.
“Additionally, sexual dysfunction may persist upon discontinuation of treatment and potentially lead to mood changes, including suicidal ideation. In this context, ANSM considers that no action proposed by the [EMA’s Pharmacovigilance Risk Assessment Committee] can satisfactorily reduce these risks.”
The declaration comes two weeks after the EMA released the results of its six-month probe, which turned up 313 cases of suicidal ideation stemming from finasteride use, and 13 from the use of fellow 5-ARI dutasteride.
And it comes just five days after the PFS Foundation broke the news that adverse reactions to finasteride soared more than 10,000 percent week over week, including 119 new reports of suicidal ideation and two new suicides.
The in-no-uncertain-terms tone of ANSM’s rejection is consistent with the position Alexandre de la Volpilière, the agency’s interim director general, laid out eight months ago in the EMA filing that set the suicidality probe in motion.
“Even though a causal association between finasteride and suicidal ideation has not been established, it was considered at least a reasonable possibility, given that known ADRs such as sexual disorders, including erectile dysfunction/impotence, depression, decreased libido, may lead to suicidal ideation,” de la Volpilière noted in that document.
While there’s no official word yet as to ANSM’s next move, a source close to the finasteride-safety negotiations with the EMA says don’t be surprised if the agency suspends or withdraws marketing authorization for the drug before year-end.
In May 2023, Organon, the Merck spinoff that now manufacturers Propecia, pulled its brand off the market in France, rather than comply with ANSM’s mandate to add a boxed warning to the outer package, leaving only generic versions of finasteride 1 mg.
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.