Macroprogestins can, for example, be prescribed for acne, endometriosis or hirsutism.
- 4 learned societies (CNGOF – SFE – SFG – FNCGM) indicate under which conditions macroprogestins can be prescribed.
- “Before initiating this treatment, a brain MRI should be performed to ensure the absence of pre-existing meningioma,” they indicate.
- “In addition, a consent form must be signed by the patient and the prescribing physician. Without this form, cyproterone acetate cannot be dispensed by the pharmacist,” they continue.
In a document entitled “Risk of meningioma and use of macroprogestins”, 4 learned societies (CNGOF – SFE – SFG – FNCGM) indicate under which conditions this type of treatment can be prescribed.
What are macroprogestins prescribed for?
“Macroprogestins are usually recommended in the treatment of benign endometrial or breast pathologies. Some of them have a strong antigonadotropic power and can therefore also be used in contraception,” summarizes the French Society of Endocrinology on its website. Concretely, macroprogestins can for example be prescribed for acne, luteal insufficiency, adenomyosis, fibroids, endometriosis or even hirsutism.
Quite rare*, meningiomas are benign brain tumors that develop from the meninges (the coverings of the brain and spinal cord) and increase with age. About 2/3 of meningiomas are potentially sensitive to progesterone-derived hormones (progestins), because they express receptors for this same hormone.
Meningioma and ANDROCUR: strict prescription rules
Some time ago, a progestin called cyproterone acetate (ANDROCUR® and its generics) was the subject of a new specific evaluation by the National Agency for the Safety of Medicines (ANSM) on the occurrence of operated meningiomas. Recommendations and strict prescription rules were then disseminated.
“Before initiating this treatment, a brain MRI should be performed to ensure the absence of pre-existing meningioma,” indicate in a joint press release the 4 learned societies (CNGOF – SFE – SFG – FNCGM) cited at the beginning of the article. “This examination is repeated after 5 years if treatment with cyproterone acetate is maintained for this entire period, then every two years in the event of use beyond 5 years”, they add.
“In addition, a consent form must be signed by the patient and the prescribing physician. Without this form, cyproterone acetate cannot be dispensed by the pharmacist.”they continue.
Meningioma and macroprogestins: “the relative risks vary depending on the molecules”
In June 2020, and more recently in two new publications from 2023 and 2024, the GIS EPIPHARE ANSM-CNAM epidemiological study evaluated the risk of operated meningiomas in women on macroprogestin-type treatment versus that of untreated women. These studies highlighted a significant increase in the risk of meningioma in the group of women treated with chlormadinone acetate (LUTERAN® and its generics which are no longer marketed in France), promegestone (SURGESTONE®, which is no longer marketed in France) but also medrogestone (COLPRONE®), nomegestrol acetate (LUTENYL® and its generics) and depot medroxyprogesterone acetate (DEPOPROVERA®). “The relative risks vary depending on the molecules. For all these macroprogestins, as for cyproterone acetate, there is a dose-effect relationship: the more the total dose taken increases, the more the risk of meningioma diagnosis increases,” explain the institutions.
“It is important to reassess the benefit/risk balance every year”
“Finally, it is important to remember that in the case of meningioma discovered in patients using macroprogestins, stopping these molecules induces in the vast majority of cases a stabilization or even a significant reduction in tumor volume,” they emphasize.
In conclusion, “vigilance is necessary during long-term use of macroprogestins because of the risk of meningiomas. It is also important to evaluate and re-evaluate each year the benefit/risk balance of this type of treatment for each patient”, write the health professionals at the end of their report.
Two applications were filed with the Montreuil administrative court
According to information from the newspaper Le Monde, women who consider themselves victims of macroprogestins are currently taking the State to court for compensation.
“Two applications have been filed with the administrative court of Montreuil. The Medicines Agency is being accused of having delayed correctly informing patients of the risk of brain tumors despite the warnings,” specifies the journalist Stéphane Mandard in an article published on March 29.
*The annual incidence of these brain tumors is very low: it is 8 to 10 cases/100,000 people/year.
