Depuis début 2019, L’ANSM alerte les professionnels de santé et les femmes sur le risque de méningiome*  associé à l’utilisation d’acétate de nomégestrol (Lutényl et génériques) et d’acétate de chlormadinone (Lutéran et génériques) dès lors que leur utilisation est prolongée et à dose élevée.

In June 2020 a vast epidemiological study made it possible to quantify this risk for the first time:

• A woman who takes one of these treatments for more than six months has approximately 3.3 times more risk of developing meningioma* compared to the basic risk

• The risk increases with the duration of treatment, and also with the dose used and the age of the patient:
  • Under Lotényl the risk is multiplied by 12.5 from five years of treatment
  • Under Luteran, it is multiplied by 7 for 3.5 years of treatment

Given these new data, preliminary recommendations have been drawn up by an expert committee (see below).

In order to establish the appropriate measures to use these progestin drugs with regard to the risk of meningioma and the needs of women for which these treatments are justified, the ANSM organizes a public consultation on Monday, November 2, 2020.

Vous êtes ou avez été traitée par Lutényl, Lutéran ou leurs génériques, ou que vous êtes professionnel de santé, consultez  les recommandations préliminaires : 

For patients

Meningioma is a tumor of the membranes that surround the brain: the meninges. Meningioma can be unique or multiple. These tumors are most often non -cancerous but can cause serious disorders, which may require heavy and risky surgery. Meningioma can develop outside any medication. 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.

Lien vers l’ANSM : https://www.ansm.sante.fr/Dossiers/Lutenyl-Luteran/Lutenyl-Luteran-et-risque-de-meningiome/(offset)/0