A FB Post Written by Sylviane Millon-mathieu
Hello everyone, we had an appointment Tuesday at the ANSM about the next information finasteride. Franck and I were accompanied by Camille LAFON and Charles JOSEPH-OUDIN. I will try to give you a brief account and at the end allow me to invite you to participate.
We note a progress in the awareness of our Health Authorities (small steps but still …) and more difficulties with prescribers (certainly for many reasons …).
Some results of this long work started in February:
-
Added persistence of psychiatric side effects. For them, every health professional must know all the disorders caused by depression including memory loss, cognitive disorders, anhedonia, …
-
Prescribers’ obligation to issue a written document and oral information to future consumers with a cooling off period between the first consultation and the order
-
Verification by the pharmacist that the patient has been correctly informed
-
Add in information the percentage of effectiveness of the product (67% fina group, 37% placebo group, which can make you think …)
-
Removal of some attenuative terms
-
Reminder that ES can be triggered during and after consumption
Of course, and just like you, we think that this is not enough in view of your expectations, your ills, but each modification has its importance for the future and if I may, each movement of a comma is a crazy job. so imagine …
We also have :
-
Request that the delivery figures be clearly stated, but a priori, it is difficult to admit that they fall more each year;
-
Reiterate our request for meetings with victims and specialists able to work on solutions;
-
Address the question of a study.
Concerning the request to add new undesirable effects to the package leaflet:
Our goal is that the leaflet is more exhaustive, we have been able to address muscle side effects, pudendal neuralgia, … and this is where you intervene!
- In order for a request for addition to be made to the EMA, the FDA, … it has to be stated that the adverse reaction is reported a number of times it seems and it worked well for the depression and the anxiety.
We had for France but it is valid for all countries, requested the anonymized consultation of the files and we were very surprised by the difference between what we hear, what we read and what is actually declared.
For example, suicidal ideation, muscular pain, intestinal problems, etc … are often debated but not reported and this is harmful …
So, I strongly urge you to take back your reports of adverse reactions by adding any necessary modifications, all medical examinations, all prescriptions of drugs intended to counter your ills, … It is extremely important to keep your files alive and keep them up to date, the duration of the ES because when this is not the case, the side effects are classified under the heading “transient”!
It will only take about ten minutes, then you can also ask for a copy of the recording because we realized that some information was wrong (sometimes only part of it is written on the sheet for example) which is detrimental for everyone.
Care path:
As you know, with regard to future “care” we are dealing with the Ministry of Health and the LRAs. We proposed that doctors and specialists familiar with the issue be heard by the authorities. Some accepted, recounted their findings and insisted on the reality of the affections. So things are set up, a priori, in each region, you can be received in a service. We are relaunching the Ministry of Health early next week and will keep you informed.
This is what we can tell you today, know that other actions are underway but we will wait to talk to you about it.
Do not forget that you are actors, many are already engaged but some still think that it is vain, that they are too exhausted to fight again, … No, it is not useless, each of us can relay info, denounce, tell, … You do not imagine how important your role is!
We hope it was not too long …
Sincerely, Sylviane, Marion, Franck, …
PS: In Italy we are doing the same through AVF -Associazione Vittime Finasteride. So guys from all over the world, gather in your states and do what we’re doing. Find good lawyers, create associations, collaborate with doctors you trust, write to the media and let the truth come out. It is the only way for have more then 2 researchers in the world working of PFS (Melcangi and Khera). If you need help write me, I will advise you.