Thanks to the results of the study of the Epi-Phare Scientific Interest Grouping, the Méningioma sur-risk in women exposed to nomestrol (lutenyl and generic) and chlormadinone (luteran and generic) acetate-mentioned since 2019-has finally been quantified. Thus, "a woman who takes one of these macroprogestative drugs for more than six months has approximately 3.3 times more risk of developing meningiom compared to the basic risk", reveals the study. This risk increases with the duration of treatment, with the dose used and the age of the patient. As proof, "under Lutényl the risk is multiplied by 12.5 from five years of treatment".

However, all the women affected by these treatments indicated in the management of menopause, menstrual disorders and endometriosis, are not yet informed of this risk. This is why the National Medicines Safety Agency (ANSM) has decided to deploy a new information system to patients and health professionals.

Information and certificate

First, the agency will provide caregivers with an information document to be given to each patient to start processing or pursue it. Its content? Explanations on what a meningioma and the level of risk is depending on the treatment taken. "He will alert clinical signs likely to be associated with the presence of meningioma and will specify the driving to be held for each situation," notes the ANSM.

In parallel, each patient and her doctor will now have to complete an annual information certificate. The goal is to ensure that the patient is well informed by her practitioner of the risks involved. This certificate must be presented in pharmacies before obtaining treatment.

These documents, inspired by those implemented in 2019 to reduce the use of another progestin medication associated with an over-risk of meningioma (Androcur and its generics), will be available during spring. If certain methods remain to be defined, the objective of these measures is the same here: "Limiting the use of these drugs to the only situations for which their prescription is justified", specifies the ANSM.

In the meantime, health professionals have already been encouraged since June 2020 to:

-Réévaluer la pertinence d’un de ces traitements en tenant compte du bénéfice-risque individuel ;
-Limiter la durée d’utilisation de ces médicaments ainsi que leurs posologies aux doses minimales efficaces ;
-Ne pas substituer les macroprogestatifs entre eux (acétate de nomégestrol, acétate de chlormadinone et acétate de cyprotérone) en cas de méningiome ou d’antécédent de méningiome ;
-Faire réaliser une IRM cérébrale en cas de symptômes évocateurs d’un méningiome ;
-Proposer aux femmes de plus de 35 ans en cas de traitement prolongé (à partir de 5 ans), une imagerie cérébrale par IRM.