The cure may prove worse than the disease, and combating hair loss by taking finasteride 1 mg can be detrimental to mental health. “Oral medications containing finasteride 1 mg pose a risk of psychiatric disorders as well as disorders of sexual function, which can lead to suicidal ideation,” warns the national medicine safety agency (ANSM) on its site.
Concerned about strengthening patient information, it has therefore set up a certificate of shared information mandatory since April 16. Doctor Philippe Vella, medical director at the ANSM, answers questions from 20 Minutes on this policy of securing finasteride, prescribed to young men suffering from premature alopecia.
Does the new information certificate associated with finasteride 1 mg make it possible to secure the prescription of this medication?
We considered it necessary to deploy this additional tool in France, although it is not necessary at the European level. This information certificate aims to ensure that the essential information relating to the use of finasteride and its psychiatric and sexual risks has been explained to the patient and that he has understood it well.
This complements numerous other actions already put in place by the ANSM to reinforce the proper use and information around the risks relating to taking finasteride 1 mg, indicated for androgenetic alopecia. An information sheet was put in place in 2019, replaced and reinforced with this new certificate. We also asked the laboratories concerned to put alert messages on the boxes of these medications, with a QR code. which links to the thematic file dedicated to finasteride which we published on our site.
After France’s request for a reassessment of the benefit-risk ratio in Europe (in 2024), a patient card informing of the risks was also integrated into the boxes. We also recommend a period of reflection between the moment the prescription is considered and the purchase of the medication in the pharmacy, and recall the importance of follow-up.
Should doctors reserve this prescription for young men who suffer a lot psychologically from hair loss?
It is also to raise awareness among prescribers that this certificate is deployed. She points out that it is a medication, in accordance with its marketing authorization (AMM), reserved for young men (18-41 years old) who come to consult for alopecia.
This can have a significant psychological impact on their lives. However, today, the conditions of MA are not subject to this criterion. But from our point of view, it is an element which must indeed be taken into account by prescribers.
The suicidal risks may seem disproportionate to the benefits of the medication, since hair loss does not present health risks. What do you think?
This is why we launched this European arbitration procedure which consisted of a reassessment of the benefit-risk ratio. And after Europe’s conclusions, considering the measures insufficient, we supplement them with this certificate.
Why not go so far as to consider withdrawing the medication?
This is a decision that the ANSM cannot make alone, it is the responsibility of Europe. The re-evaluation procedure could have concluded with a withdrawal decision but it considered that the benefit-risk ratio of the use of this product in accordance with the MA criteria remained positive, provided that patient information was strengthened, in particular through a patient card (proposed by Europe).
France has gone above and beyond to ensure that patients make an informed decision to take this treatment. The certificate is particularly detailed and explicit on this point.
Does finasteride remain under the surveillance of the ANSM?
Of course, we continue to monitor this drug closely. And if we considered that new data required us to contact Europe again, we would do so.
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The problem of risks associated with this medication is not restricted to France or even Europe. Canada, for example, has taken measures, and the United States is also looking into the problem.
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