As of 2018, the National Health and Medicine Agency confirms the proven links between taking progestin drugs such as Androcur and the development of meningiomas, brain tumors. Since then, an association, Amaeva, has been fighting so that information goes both to patients and health professionals.
Charlotte, a 50 -year -old Puydômoise, has suffered from endometriosis since adolescence. For several years, she took progestin treatments in order to relieve pain due to this gynecological disease which colonized all her digestive tract. Today, after several surgical interventions, she finally has the impression that endometriosis is part of her past; that a painless life can finally begin.
Nevertheless, a few days ago, she discovered on the Internet the existence of women's fight against meningiomas after having been treated, for many years, with progestin drugs such as Androcur, Lotényl, Lutéran and their generics. There, his blood is only one tour ... "I took Androcur for years and I was not told anything about the risk of making meningiomas! ", She panics. Should Charlotte worry today? Should she take steps? Who can she learn about?
Lack of information
It is in particular to fight against this lack of information that Emmanuelle Huet-Mignaton created, in 2019, the Amaeva association (Méningiomes Association due to cyproterone acetate, aid to victims and taking into account other molecules). For fifteen years, she was treated with Androcur and Lotéran and developed five meningiomas causing her hemiplegia, aphasia. It will take two years of rehabilitation to speak properly again. Financial analyst, she will not be able to resume her professional activity.
"By creating this association, my objective was not to have these progestinic treatments which are effective, particularly in endometriosis, nevertheless, from the moment as the ANSM (National Agency for Medicines and Health Products) has established a link between these long -term drugs and a risk of meningiomas, doctors and patients must be informed of potential risks" from Amaeva.
Inform both patients and doctors
"Patients should be clearly informed of possible symptoms, neurological signs of meningiomas in order to be taken care of early and they must benefit from follow -up that does not systematically exist: pass control MRI. The ANSM notably recommended that the ascending dose as possible is prescribed. Doctors must therefore think more about their prescriptions, ”she adds.
Our goal is not to panic, especially since women who have taken these progestin treatments but who stopped them a long time ago, can remain relatively calm, it is a question of informing both patients and doctors.
Hundreds of court queries
In March 2024, two requests were filed with the Administrative Court of Montreuil (Seine-Saint-Denis) implicating the State for lack of information. Dante, in Paris, has received several hundred complaints to study.
Today, the Amaeva association has more than a thousand members, including many women suffering from endometriosis and who have had meningiomas after taking progestins.
For any info: Amaeva.org. There are Amaeva volunteers in the regions: Séverine for Auvergne-Rhône-Alpes. Contact: aura@amavea.org.
What is progestin drugs?
Progestatives are drugs used in various gynecological pathologies (endometriosis, fibroids, particularly long and/or abundant rules, cycle disorders), in the substitute hormonal treatment (including menopause); But also in obstetrics (sterility by luteal insufficiency, repeated abortions).
What is a meningioma?
The meningiomas are tumors of the membranes that surround the brain. These tumors are sometimes described as "benign" because they are not likely to degenerate into fatal cancers, but they can cause serious neurological handicaps. In the general population, it is estimated that 9 out of 100,000 are likely to develop meningiom each year. Meningioma represents more than one primary brain tumor (without metastasus) in three. It is the most common brain tumor from 35 years old. Age, female gender and exposure to ionizing radiation in childhood (diagnostic imaging examination, scanner, scintigraphy) constitute clearly identified risk factors.
How are these prescriptions supervised at the CHU
Last May, the ANSM again alerted health professionals about the risks of meningioma in patients who receive prolonged progestin treatments (several months or years). How are these prescriptions supervised to the Clermont-Ferrand University Hospital?
Link proven by studies dilligent by ANSM
Between 2019 and 2020, successive epidemiological studies have demonstrated a risk of meningioma that increases with the dose received, for three progestins (Androcur, Lutenyl, Lotéran and Generics). Following these studies, the ANSM then implemented measures to limit this risk.
What about prescriptions in France?
In France, prescriptions have decreased very significantly since the first alert at the end of 2017. They would have fallen by almost 90 % between January 2018 and December 2023. At the end of November 2023, less than 10,000 patients were processed by Androcur against around 90,000 at the end of 2017.
Changes in Auvergne
In Auvergne, at CHU Estaing in Clermont-Ferrand, in the gynecology department, expert in endometriosis, where are we of these prescriptions?
“It can be noted that the indications and the doses used have changed. No more patient receives this treatment for endometriosis in our service, ”underlines Professor Michel Canis, gynecologist at the CHU Estaing.
“For several years, the use of other drugs for which a proven risk has been demonstrated, such as chlormadinone acetate (luteran and generic), numegestrol (lutenyl and generic), are no longer prescribed in a prolonged manner. The current treatments have been stopped and at the slightest clinical doubt an MRI is requested, "he continues. Similarly, Medrogesterone (Colprone) and medroxyprogesterone acetate (DEPO Provera) are no longer prescribed.
Follow -up for patients treated in the past
However, at the CHU, many women suffering from endometriosis have been treated in the past with these progestins. Among them, according to the doctor, a patient was made of meningioma.
"These drugs were prescribed in the service to treat patients who had severe pain, clinical benefit was much higher than the risk. We are one of the only countries in which these effects have been identified, because we have prescribed more progestins and we have a rather efficient health system, ”he comments.
"For patients who have taken these treatments for several years, and who currently have no treatment, if they have no clinical sign (see elsewhere), they have nothing to do. It is likely that if they had anomalies, they would already know. »»
In a press release, the CNGOF (National College of French Gynecologists and Obstetricians) recalls that in the event of meningioma discovered in patients using macroprogestatives, the stop of these molecules induces in the vast majority of cases, stabilization or even a significant reduction in tumor volume.
Monitoring of current patients
“For several years now, we have been informing patients that you have to perform exams if prolonged progestin treatment has been used. The prescription is very supervised. Likewise, we make MRIs for patients taking prescribed progestins currently but for whom the risks are not yet known, perhaps due to much more recent use. We always use the lowest possible dosage. »»
What about other progestins?
Regarding other progestogen treatments, "you must reassure patients who take progesterone for the treatment of their menopause (utrogestan and generic), Dydrogesterone (duphaston) or who are bearers of progesterone: no surrisque has been highlighted for these treatments, interrupting them as a result of these alerts is not necessary. IUDs have extremely low doses. We are not at all in the same proportions. No particular concern is justified, these drugs have been prescribed for several decades, no increase in the risk of meningioma has been highlighted, "said Professor Canis. And to add that "the treatments of a few weeks do not increase this risk either. »»
Study in progress. In 2023, the ANSM observed cases of meningioma occurring during treatments by other progestins. It established first recommendations in order to supervise this risk for Médrogestone (Colprone), progesterone progestins at 100 mg and 200 mg (utrogestan and generics), Dydrogesterone (Duphaston) and Dienogest (Generics de Visanne), pending results of in progress epidemiological studies.
ANSM recommendations
Among the recommendations, the ANSM recommends that it is necessary, before any new prescription or switch between progestins, to verify all the progestins already used and their duration of use. The treatment must be prescribed at the minimum effective dose with the shortest possible duration of use. The interest in continuing treatment must be reassessed every year, especially around menopause, the risk of meningioma increasingly increasing with age. A brain MRI will have to be carried out in the event of clinical signs evocative of a meningioma: headache, vision, language, memory and hearing disorders, nausea, dizziness, convulsions, loss of smell, weakness or paralysis. ANSM.SANTE.FR
Michèle Gardette
Michele.gardette@centrefrance.com
