Move comes less than a month after France instituted mandatory informed consent in the drug’s prescription process
May 12, 2026
When it comes to cracking down on PFS, Mother England is channeling France.
Life-saving advice?
Those measures—which include a new warning on the finasteride 1 mg label that sexual dysfunction may contribute to mood disorders—were formulated after a three-month review of (a) medical literature cited in the European Medicines Agency’s 2025 finasteride-safety probe, (b) actions taken by regulators in other nations, and (c) local pharmacovigilance (aka Yellow Card) data.
For the latter, the MHRA compiled all its reports of 5-ARI-related suicidality between 1994 and May 31, 2025, turning up:
• finasteride suicidal ideation: 170 cases
• finasteride suicides: 19 cases
• dutasteride suicidal ideation: 5 cases
• dutasteride suicides: 0 cases
The agency also noted that “prescribing data suggests more than 400,000 prescriptions per month are issued for finasteride 5 mg- and dutasteride-containing medicines.” As finasteride 1 mg is available only by private prescription, accurate prescription numbers for that dosage are not available.
In addition to expanded product-label warnings, the new safety measures include:
• Advising healthcare professionals that finasteride is associated with depression, suicidal ideation and sexual dysfunction that may persist post-treatment.
• Informing patients of these risks at point of prescription, and instructing them to read the patient card (introduced in 2024) and product leaflet included in all finasteride 1 mg and 5 mg products.
• Counseling healthcare professionals to review patients’ medical records, specifically asking if they have any history of depression or suicidal ideation, and to inquire regularly about psychiatric and/or sexual side effects.
The French Connection
In February, French drug regulator ANSM announced plans to slap yet-stricter regulations (English) on finasteride 1 mg, namely in the form of a shared-information certificate.
That measure, which took effect April 16, requires anyone using finasteride 1 mg for the first time to sign a form spelling out the myriad risks—including suicidal ideation—that the drug poses to human health. Each prescribing doctor is required to sign as well.
The certificate also spells out what to do in the case of psychiatric and/or sexual disorders, along with the importance of taking time to consider the risks before starting treatment, and the need for regular medical follow-up during treatment.
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.
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.” In April 2026, Mumbai, India-based Sun Pharmaceutical Industries agreed to acquire Organon in a deal worth $11.75 billion US.
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.