– premenopause (irregular periods, premenstrual syndrome, breast tension, etc.);
– non-severe mastodynia.
According to an Epi-Phare study, nearly 30,000 women were exposed to medrogestone monthly in 2022 (1).
2 What risks?
This study shows that prolonged use of promegestone (Surgestone, 0.5 mg, 0.250 mg, 0.125 mg, tablet), medrogestone (Colprone® 5 mg, tablet) or medroxyprogesterone acetate (Depo Provera® 150 mg/ 3 ml, suspension for injection) is associated with an increased risk of meningioma (beyond one year of use). “It’s not really a scoop for us, it’s something that was expected,” underlines Odile Bagot, obstetrician-gynecologist, also known under the pseudonym Mam Gynéco. Meningiomas have progesterone receptors, so they are sensitive to taking macroprogestins. [NDLR. dont fait partie la Colprone®]. »
“Meningioma [NDLR. tumeur primaire du système nerveux central] is a predominantly benign tumor,” it is however indicated in the study.
Recognized risk factors for meningioma
Recognized risk factors for meningioma include: female gender, age (especially age over 65 years), intracranial exposure to ionizing radiation particularly in childhood, neurofibromatosis type 2, and exposure to certain progestins (2).
3 Colprone ® but not only…
Colprone ® is, however, not the only progestin in the sights: in a letter from the ANSM of May 2024 and addressed to general practitioners, gynecologists, endocrinologists, radiologists, neurologists and neurosurgeons, midwives and pharmacists, it is very clearly written that “these progestins increase the risk of meningioma. You must respect the specific conditions of use and ensure specific MRI monitoring of your patients. »
The progestins in question:
– Cyproterone acetate 50 and 100 mg (Androcur ® and generics);
– Chlormadinone acetate 5 or 10 mg (Lutéran ®);
– Nomegestrol acetate 5 mg (Lutényl ® and generics);
– Médrogestone (Colprone ® 5 mg) ;
– Medroxyprogesterone acetate (Depo Provera ®150 mg/3 ml).
“Given that there have been significant restrictions on Lutéran® and Lutényl®, Colprone® has been prescribed a lot,” emphasizes Dr. Bagot.
4 What recommendations?
Between July 2023 and June 2024, the ANSM issued several recommendations to reduce the risk of meningioma associated with the use of these five drugs:
– if there is a history of meningioma or existing meningioma, progestogen treatment should not be used.
– Progestins should be prescribed at the minimum effective dose and for the shortest possible time (because the risk of meningioma increases with age, dose and duration of exposure).
– The prescription of these medications must be re-evaluated every year, particularly around menopause for women.
– Imaging monitoring: an MRI must be performed at the start of treatment in the event of an identified risk factor for meningioma. In all cases: an MRI after one year of treatment with one of the progestins mentioned, one five after the first then every two years if treatment continues.
– If signs suggestive of a meningioma appear during or after treatment with a progestogen, and even if the treatment stopped several years ago, an MRI must be performed.
– If a meningioma is diagnosed, progestin treatment must be stopped immediately.
– The prescription of Colprone® should only be justified as first intention in cases of bleeding linked to fibroids, endometriosis or severe breast pain (mastodynia). For other cases, the ANSM recommends “first-line use of progestins not associated with an increased risk of meningioma, or resorting to therapeutic alternatives”. Regarding Depo Provera®, it should only be used when it is not possible to use other contraceptive methods.
– Finally, since July 1, 2024, the conditions for prescribing and dispensing medications based on medroxyprogesterone acetate (Depo Provera® 150 mg/3 mL) and medrogestone (Colprone® 5 mg) have been strengthened: the prescription must be accompanied by an annual information certificate co-signed by the prescriber and the patient for treatments lasting more than one year. This is a mandatory condition for the medicine to be dispensed to you. In addition, an information sheet must now be provided to the patient by the prescriber.
Practical
(1) Epi-Phare, is a scientific interest group formed by ANSM and Cnam. Read the study.
