06 mars 2023
In order to reduce the increased risk of meningioma associated with taking several categories of progestins, the Medicines Agency issues a series of practical recommendations.
After Androcur, Luteran and Luteran and its generics, the National Medicines Safety Agency (ANSM) has “observed cases of meningioma occurring during treatment with other progestins”. Medrogestone (Colprone), progesterone 100 mg and 200 mg (Utrogestan and generics), dydrogesterone (Duphaston) and dienogest (generics from Visanne) are indicated in various gynecological pathologies (endometriosis, fibroids, particularly long and/or heavy periods, cycle), in hormone replacement therapy (including menopause); but also in obstetrics (sterility due to luteal insufficiency, repeated abortions).
The temporary scientific committee (CST) convened to assess the link between these molecules and these primary brain tumors, “believes that a “class” effect of progestins on the risk of meningiomas cannot be excluded”, notes the ANMS. That’s why she has “established the first recommendations to limit this risk pending epidemiological studies, conducted by Epi-Phare, to confirm or invalidate this risk. »
Precautionary recommendations
First of all, the prescription of a progestogen treatment is contraindicated in the event of a history of meningioma or existing meningioma. And this, except for exceptions to be evaluated in a multidisciplinary consultation meeting.
Changing the progestogen does not exclude the risk of meningioma, however, “untold for the moment we can determine it”specifies the ANSM. “It is necessary, before any new prescription or switch between progestins, to check all the progestins already used and their duration of use”.
When it is nevertheless indicated, “the treatment (by these progestogens, editor’s note) must be prescribed at the minimum effective dose with the shortest possible duration of use”.
“The benefit of continuing treatment should be reassessed every year, especially around menopause, as the risk of meningioma increases sharply with age”adds the agency.
Finally, “A cerebral MRI should be performed in the event of neurological clinical signs suggestive of a meningioma (headaches, vision, language, memory and hearing disorders, nausea, dizziness, convulsions, loss of sense of smell, weakness or paralysis)”.