Approximately 30,000 men in France use finasteride 1 mg to treat androgenetic alopecia, but obtaining the drug now requires more than a standard prescription. Starting April 16, 2026, the Agence nationale de sécurité du médicament (ANSM) requires a co-signed annual attestation from both the patient and their physician to trigger the delivery of the medication at pharmacies.
Psychiatric risks drove the regulatory shift
The ANSM’s decision follows years of warnings regarding severe side effects. Although the drug effectively slows hair loss, it carries risks of mood disorders, depression, and suicidal ideation. A pharmacovigilance report published last September analyzed 110 cases of psychiatric disturbances. The data showed that 39% of these patients experienced “dark thoughts,” and the report documented four suicide attempts and one death.
The findings suggest these reactions aren’t always linked to pre-existing conditions. Only a quarter of the psychiatric cases had identifiable prior mental health history or favorable circumstances for such an onset. More concerning is the permanence of these effects; the study found that these disorders were irreversible in only half of the cases analyzed.
What patients must provide to pharmacists
A simple medical order is no longer sufficient for a first-time prescription. Patients must present a two-page “annual shared information attestation.” This document replaces the basic information sheets used since 2019 and forces a documented dialogue between the doctor and the patient.
The form includes a preamble describing the treatment, useful links for reporting side effects, and a checklist. This list covers potential adverse reactions, the required medical follow-up, and the specific conduct to adopt during treatment. Both parties must sign the document to certify the patient is aware of the risks, including those that may persist after the medication is stopped.
Timeline for existing users
New patients faced the requirement immediately on April 16. Those already receiving treatment have a grace period to consult their general practitioners and regularize their files. These existing users must produce the signed attestation for any prescription renewals starting June 16, 2026.
This tiered rollout aims to prevent sudden disruptions in care for the thousands of men, often young, who rely on the drug to manage their hair loss. The ANSM is effectively shifting the burden of proof to the physician to ensure no patient starts the regimen without a period of reflection.
European authorities maintain the benefit-risk ratio
The European Medicines Agency (EMA) and its pharmacovigilance committee (PRAC) re-evaluated finasteride in 2025 following requests from France. The EMA confirmed the reports of suicidal ideation but didn’t ban the drug. Instead, it concluded that the therapeutic benefits still outweigh the risks, provided that vigilance and patient information are strengthened.
This approach reflects a standard pharmacovigilance logic. When a treatment remains clinically useful but presents grave risks, regulators opt for stricter guardrails rather than a total market withdrawal. The focus is now on traceability and informed consent.
Does this apply to all forms of finasteride?
No. These new requirements specifically target the 1 mg dose used for calvitie. Finasteride 5 mg, which is prescribed for prostate issues, is not subject to this attestation requirement.
What sexual side effects are associated with the drug?
Beyond psychiatric risks, the medication is linked to sexual dysfunction, including a decrease in libido and erectile dysfunction.
How often does the attestation need to be renewed?
The document is valid for one year and must be renewed annually through a new consultation and co-signature with a physician.
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