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:

• il faut toujours voir la balance bénéfice/risque d’un médicament. Voir pourquoi vous le prenez et si vous pouvez vous en passer. Pour l’endométriose ou le SOPK (ovaires polykystiques), c’est très difficile parfois de vivre une vie « normale » sans. Mais on peut prendre ces traitements pour beaucoup d’autres raisons, et aucune n’est à négliger !
  Beaucoup de médecins gynécologues ne relaient pas cette information capitale de l’ANSM:Savoir si vous avez des signes neurologiques qui pourraient indiquer que des méningiomes sont là, C’EST LE PLUS IMPORTANT. **
  https://amavea.org/symptomes-du-meningiome/

Tout en sachant qu’un méningiome peut être « silencieux » longtemps et ne donner aucun signe vraiment parlant, mais que des maux de tête diffus et une fatigue qui s’installe.
Il faut en discuter avec un médecin, et vous pouvez aussi en discuter sur ce groupe.

????‍♀️ Cependant si vous avez des doutes, seule l’IRM avec injection peut lever le doute (attention au scanner qui ne permet pas de voir tous les méningiomes, les autorités de santé préconisent bien des prescriptions d’IRM et non de scanner) .

Texte de l’ANSM ici :
https://ansm.sante.fr/S-informer/Actualite/Lutenyl-Luteran-et-generiques-recommandations-preliminaires-suite-a-la-confirmation-du-sur-risque-de-meningiome-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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