ANSM- CST meeting of June 8, 2020- Méningiomes and Lotéran, Lotényl, Progestififies

ANSM ANDROCUR
ASM message to the association.


CST meeting on Monday, June 8, 2020
meningiomas and progestins (Lotéran Lotényl, etc.) The ANSM wishes to share with you information on the risk of the occurrence of meningioma associated with the use of nomestrol (luteran and generic) or chlormadinone acetate (Lentenyl and Generics).
As you know, an epidemiological study was conducted by the Epi-Phare scientific interest group, made up of the ANSM and the CNAM, in order to quantify this risk according to the duration of treatment and the cumulative dose and thus to determine whether women using these drugs have a higher risk of meningioma than that observed in the general population.
These all new results will be presented and discussed Monday June 8 with the members of the temporary scientific committee (CST) progestin and risk of meningiomas, consisting in particular of gynecologists and endocrinologists to prepare the second working time, which will be held in consultation with stakeholders after summer, and will concern the risk reduction measures to consider .

This CST had already brought together in October 2019 ( ( https://www.ansm.sante.fr/s-informer/points-d-information-d-information/l-ansm-poursit-ses-travaux-sur-les-progestififies-et-le-risque-de-meningi-mening-information ) with the aim of defining epidemiological study.

???? We plan to publish an information point following Monday meeting . This communication will report on the results of the study and aims to raise awareness among new health and patients at the risk of the occurrence of meningioma associated with these drugs. We will of course relay you the information point so that you can disseminate it to your networks.

???? As a reminder, in line with the actions carried out for several years around cyproterone acetate ( Androcur and generic ), the cases of meningiomas associated with the use at therapeutic doses of chlormadinone acetate or nomestrol acetate led the ANSM to send a letter to healthcare professionals in February 2019 https://www.ansm.sante.fr/s-informer/informations-decurite-lettres-aux-professionnels-de-sante/acetate-de-chlormadinone-luteran-r-et-generiques-cetate-de-nomegestrol-lutenyl-r-et-generiques-risque-de-survenu ) to inform them about this risk and remind them that:
-Lotényl , Luteran and their generics are contraindicated in the event of existence or history of meningioma;

- Any diagnosis of meningioma in a patient treated by Lotényl, Luteran or their generics, must lead to the immediate and definitive stop of the treatment.

In addition, a pharmacovigilance survey was presented at the ANSM and members of the permanent scientific committee "surveillance and pharmacovigilance" in November 2019, in the presence of patient associations.

 

ANSM- CST meeting of June 8, 2020- Méningiomes and Lotéran, Lotényl, Progestififies