French Drug-Regulatory Authority Unveils World’s Most Thorough PFS-Prevention Program

‘How-to’ video encourages reporting of finasteride ADRs to Ministry of Health

July 13, 2022

Dear Friends:

France’s National Agency for the Safety of Medicines and Health Products (ANSM) last week published a dossier of educational materials on the growing number of adverse drug reactions (ADRs) to finasteride 1 mg, as experienced by men currently suffering from post-finasteride syndrome (PFS).

Arguably the most thorough and vigilant PFS-prevention campaign ever produced by a drug-regulatory authority (DRA), the content was developed in collaboration with French patient-advocacy group Aide for Victims of Finasteride (AVFIN), and is housed on the ANSM website in six parts:

1. Finasteride 1 mg for the treatment of early-stage hair loss (English): “This file details important messages and presents actions to be taken, both for patients and health care professionals, when starting treatment, and in the context of the patient follow-up by health care professionals. Considering the impact that some of the adverse reactions associated with finasteride can have on the patient’s quality of life, it is essential to be aware of them before starting treatment. By the same token, it is important that a rigorous and regular medical follow-up is conducted during treatment. This requires an in-depth discussion between the patient and his doctor before any prescription is written.”

2. Finasteride 1 mg and hair loss (English): “By preventing the formation of DHT in the body, finasteride can stabilize hair loss. In humans, DHT is involved in the development of secondary sexual characteristics (body hair, muscle mass, etc.), as well as in reproductive functions. Therefore, although the desired action of finasteride is the reduction of the level of DHT in the hair follicles, other organs can be impacted.If drugs based on finasteride 1 mg manage, in certain cases, to combat androgenetic alopecia, the hormonal action of finasteride could be the cause of sometimes severe adverse effects, in particular of a psychological, sexual, and/or physical nature."

3. Risks of taking finasteride 1 mg (English): “Patients have reported sexual disorders when using finasteride 1 mg. These may include erection disorders, ejaculation disorders…testicular pain, a decrease in libido, as well as male infertility problems and/or poor semen quality... Patients have also reported mental disorders, including anxiety, depression, [and] suicidal thoughts that could lead to suicide. Symptoms of depression may include constant sadness, depression, loss of interest and/or pleasure, difficulty concentrating and/or remembering, reduced energy and/or fatigue (abnormal or even intense), and sleep disorders. All of these disorders can have an impact on social and professional life. Sexual and psychological disorders may persist after stopping treatment for an indefinite period."

4. Information for patients treated with finasteride 1 mg (English): “It is important to remain vigilant for the appearance of worrying/unusual signs, even if they seem trivial to you or you are embarrassed to talk about them. Do not hesitate to discuss any such signs with your doctor at each follow-up consultation of your treatment… It is also recommended that you inform your relatives that you are taking finasteride, inform them of possible adverse reactions, and ask them to alert you if they observe any changes in your behavior."

5. Information for healthcare professionals about finasteride 1 mg (English): “Remember that finasteride 1 mg has a hormonal action and can cause mental disorders and sexual disorders… Given the nature of the adverse effects, in particular those of a psychological nature, it is advisable to schedule a follow-up consultation within three months after initiation of treatment, to assess its tolerance, then regularly (for example, every six months) during treatment."

6. How to report adverse reactions to finasteride (French only): Produced by the Regional Pharmacovigilance Center of Limoges in collaboration with ANSM and AVFIN, “this interactive video complements the tools available to educate patients and healthcare professionals about the risks associated with finasteride use. It provides a step-by-step guide for anyone wishing to report an adverse reaction potentially linked to taking this medicine” to the French Ministry of Health’s portal for adverse health events. Notably, the array of possible adverse reactions presented on page 11 of the video (above) is divided into 44 psychological, sexual, hormonal, and other disorders, ranging from insomnia to tinnitus to memory loss to pudendal neuralgia.

According to ANSM, updated finasteride product literature mirroring the content of the agency’s new educational dossier is forthcoming.

Anyone living in the US who suffers from PFS should report his symptoms to the US FDA. Anyone living outside the US who suffers from PFS should report his symptoms to the US FDA as well as to his or her local DRA, as directed on our Report Your Side Effects page.

Finally, 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.

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