This follows the ANSM’s request to reassess the benefit/risk balance of finasteride and dutasteride, the latter belonging to the same pharmacological class as finasteride.
Finasteride 1 mg is indicated for the early stages of androgenic alopecia in men aged 18 to 41 years. Finasteride 5 mg as well as dutasteride 0.5 mg are used in the treatment of benign prostatic hypertrophy and the prevention of associated urological disorders. It has no indication in women.
These medications present risks of sexual dysfunction and psychiatric disorders which are described in the instructions and for which we maintain monitoring. The risks associated with finasteride 1mg are all the more closely monitored as this medication is used in the early treatment of androgenetic hair loss, in young, healthy men.
Since 2019, we have been taking action to strengthen the provision of good information to patients and healthcare professionals on the risks associated with finasteride 1mg and to enable the identification of adverse effects:
- publication of a information sheet for patients and sending a letter to healthcare professionals to inform about the risks of sexual dysfunction and psychiatric disorders;
- publication of a dedicated thematic file to gather information on the proper use of finasteride 1mg and its risks;
- reminder of the importance of reporting the adverse effects of finasteride 1mg and provision of an explanatory video to facilitate this reporting, including psychiatric and/or sexual effects;
- affixing alert messages to medication boxes containing finasteride 1mg informing patients of the risks of psychiatric and/or sexual disorders linked to these medications;
- direct information by ANSM e-mailing prescribing doctors, doctors likely to see patients presenting adverse effects of finasteride 1mg, as well as pharmacists in order to remind them of the role that finasteride can play in triggering psychiatric and/or sexual disorders and the need to be attentive.
The ANSM ensures continuous monitoring of adverse effects linked to finasteride, particularly via pharmacovigilance declarations, and regularly communicates with stakeholders.
Despite these actions, serious cases of psychiatric disorders and sexual disorders (which can sometimes persist long after treatment has stopped) continue to be reported to us. Additionally, suicidal ideation has recently been recognized as a potential adverse effect for two medications containing finasteride (Propecia 1 mg and Chibro-Proscar 5 mg). This request for re-evaluation is particularly important for finasteride 1 mg given its indication only in alopecia, a condition without danger to health affecting young men.
Information for patients
If you are being treated with finasteride or dutasteride, and you suffer from psychological disorders (changes in mood, anxiety, signs of depression, suicidal thoughts) or sexual disorders (erection problems, ejaculation problems, decreased libido, etc.), this may come from your treatment:
- Talk to your doctor as soon as possible;
- If you are being treated for alopecia, in the event of psychological problems, stop your treatment;
- Report an adverse reaction.
If these effects last over time or persist after treatment is stopped, it is important to update your initial declaration to complete it.
Information for healthcare professionals
If some of your patients report changes in mood, anxiety, mention signs of depression or suicidal thoughts, or talk to you about sexual problems such as erectile dysfunction, ejaculation problems, decreased libido, ask them about current or past treatment with finasteride or dutasteride. These symptoms could be linked to it.
Monitor any patient known to be or has been treated with finasteride or dutasteride for such symptoms.
If these symptoms appear, you will need to assess whether to continue or stop treatment.
Report any adverse effects reported to you.
Source: ANSM news from 10/17/2024
