Shared-information certificate, co-signed by doctor, must be renewed annually
Feb. 8, 2026
Dear Friends:
Scoring finasteride in France just got beaucoup plus difficile.
Last week, the nation’s drug-regulatory authority slapped yet-stricter regulations (English) on the embattled hair-loss drug, namely in the form of what it calls a shared-information certificate.
Co-vigilance
Beginning April 16, anyone taking finasteride 1 mg for the first time must sign—along with the prescribing doctor—a form that spells out the myriad risks the drug poses to human health, including:
▪ Psychiatric disorders (depressed mood, depression, suicidal thoughts);
▪ Sexual dysfunction (including erectile dysfunction, ejaculation disorders, decreased libido);
▪ The possible persistence of certain effects after discontinuation of treatment.
The certificate also spells out what to do in such cases—namely, quit the drug and seek immediate medical attention—along with the importance of taking time to consider the risks before starting treatment, and the need for regular medical follow-up during treatment.
Designed to help ensure that doctors thoroughly review with patients the possibility of life-altering adverse events arising from finasteride use, the certificate is valid for one year. After that, it must be renewed annually. And it must be presented by the patient to the pharmacist for each new prescription and refill.
Patients currently on finasteride 1 mg have until June 16 to begin presenting the certificate at pharmacies, allowing them time to consult with their doctor.
Could a ban be on L’Hexagone’s horizon?
By far the world’s most vigilant nation when it comes to PFS prevention, France has been instituting new safety measures for 14 years now.
Those efforts kicked into high gear nearly a decade ago, when Caroline Semaille, MD, then ANSM’s director of dermatology, launched a media tour, during which she told France 3 News: “Depressive disorders [stemming from finasteride use] have not yet been formally established, but we have doubts and prefer therefore to inform the public.”
She also told Le Parisien: “We know [these adverse drug reactions] are undervalued, because France does not have much pharmacovigilance reflex. And, worldwide, 508 serious psychiatric cases, including 25 suicides, have been identified… From now on, you’re informed. So you decide.”
Since then, according to the World Health Organization’s VigiBase database of ADRs, the number of finasteride-related suicides has risen 400%, to 125. And the number of finasteride-related psychiatric disorders has risen more than 1,000%, to 6,292.
Here’s a breakdown of ANSM actions to date:
▪ 2012: Issued a safety alert about persistent sexual ADRs linked to finasteride use for hair loss.
▪ 2017: Issued a safety alert for patients and health providers that treatment should be discontinued if mood changes occur.
▪ 2019: Issued an information sheet for patients considering finasteride use for hair loss, explaining what to do in the event of ADRs, including mood changes.
▪ 2022: Launched an awareness campaign for health providers and the general public, featuring a video on the importance of patients filing ADR reports.
▪ 2023: Mandated that a red-box warning be added to finasteride 1 mg packaging indicating that sexual and/or psychiatric ADRs may occur during and post-treatment, along with a QR code linking to a new educational section of the ANSM website.
▪ 2024: Demanded that the European Medicines Agency conduct a continent-wide safety probe focused on suicidality risks, which resulted in suicidal ideation being added to the label as an official side effect.
Notably, in the wake of ANSM’s 2023 red-box warning mandate, current Propecia manufacturer Organon withdrew its product from the French market, leaving only generic versions of finasteride 1 mg.
For a complete list of all known finasteride-safety actions taken to date by drug-regulatory authorities, please consult our PFS Global Warning Map.
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.