Lutényl & Lotéran and Generics: Preliminary recommendations following confirmation of the Méningiome sur-risk- June 17, 20206 ANSM

Information Lutényl & Lotéran dated June 17, 2020

The National Agency for the Safety of Medicines and Health Products (ANSM) contacted us yesterday to inform us of the results of the study conducted recently on the Luteran and Lutenyl and confirmed to us that like the Androcur, these 2 progestins include risks of meningiomas, more or less risks according to the dosage and the length of prescription.

We will participate as for Androcur, in the working group that the ANSM will set up and in which we will be invited to express ourselves and to debate. We will do everything not to serve as a deposit for the ANSM on decisions with which we would not be fully in agreement. We are aware of the great difficulty that for people with endometriosis, the situation can be anxiety -provoking and complicated. However, in this group you have people who have effective and risk -free management.

Since the start of the association (January 2019), we have made messages to the news on the Facebook group (which no other group does), with the following information, which concern all the progestins. So for the members of this group who have been there for several months, this news will only confirm what we already know. ::

???? If you are there because you have taken Androcur, Lotéran, Lotényl or another progestogy, and you ask what to do:

• You always have to see the benefit/risk balance of a drug. See why you take it and if you can do without it. For endometriosis or sopk (polycystic ovaries), it is very difficult sometimes to live a "normal" life without. But we can take these treatments for many other reasons, and none is to be overlooked!
  Many gynecologists do not relay this capital information of the ANSM: to know if you have neurological signs which could indicate that meningiomas are there, that is the most important. **
  https://amavea.org/symptoms-du-meningiome/

Knowing that a meningioma can be "silent" for a long time and give no really speaking sign, but that diffuse headaches and a fatigue that settles.
You have to discuss it with a doctor, and you can also discuss it about this group.

???? ‍♀️ However if you have doubts, only the MRI with injection can lift doubt (beware of the scanner which does not allow you to see all the meningiomas, the health authorities recommend many MRI prescriptions and not to scan).

Text from the ANSM HERE:
https://ansm.sante.fr/s-informer/actualite/lutenyl-luteran-et-generiques-recommandations-preliminaires-suite-a-la-confirmation-du-sur-risque-de-meningiomé-point-d-Information

According to the ANSM, for patients, the information is as follows:

Meningioma is a tumor, most often benign, which develops from the membranes that wrap the brain and the spinal cord (the meninges).

• If you are currently processed by nomestrol (lutenyl and generic) or chlormadinone acetate (luteran and generics), we invite you to consult your doctor to discuss your care;

• If you are over 35 years old and you are treated by nomigestrol (lutenyl and generic) acetate) or chlormadinone (luteran and generic) acetate for over 5 years, your doctor will be able to offer you a brain imagery (MRI);

•  If you are, or have been, treated by nomestrol (lutenyl and generic) acetate) or chlormadinone (luteran and generic) acetate and you have symptoms evocative of meningioma (frequent headaches, vision, language or hearing disorders, dizziness, memory disorders, etc.), consult your doctor who will prescribe a cerebral imaging (MRI);

• If you have questions, talk to your doctor.

We also draw the attention of patients and healthcare professionals that several progestin treatments are currently in supply tension, or even in a stock situation. On the other hand, certain drugs will not be marketed in France soon and definitively will soon be more marketed following decisions taken by the laboratories that make them (Surgestone, marketed by the Serb laboratory, and Lutéran, marketed by the Sanofi laboratory).

In this context and with regard to the results of the epidemiological study, we invite health professionals and patients to initiate a common reflection as to the opportunity to initiate or pursue treatment with these drugs.

The association and the Dante cabinet will make a press release this day

Lutényl & Lotéran and Generics: Preliminary recommendations following confirmation of the Méningiome sur-risk- June 17, 20206 ANSM

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