Due to an increased risk of benign tumor of the brain, the drug Agency recommends that women treated for over 5 years by Lutéran or Lutényl of an MRI. Lighting Geoffroy Robin, gynecologist.
Chlormadinone acetate (Lutéran and generic) and the acetate nomégestrol (Lutényl and generic), two progestin indicated for the treatment of gynecological disorders ranging from fibroids, endometriosis, mastopathies, etc., but also used as contraceptives, induce a risk of meningioma, was alerted on the 17th of June, the Agency of the drug (MSNA).
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To know more about meningioma
Meningioma : symptoms and treatment of this brain tumor
The MSNA is based on an epidemiological study* according to which the women whose treatment duration exceeds 6 months see triple their risk of meningioma compared to women not exposed. It increases with the dose used and duration of treatment : risk multiplied by 12.5 in after 5 years of Lutényl and 7 after 3.5 years of Lutéran. It would also be 3 times higher for women aged 35 to 44 years old than for those 25 to 34 years.
Following this study, the MSNA recommends that healthcare professionals to reevaluate the relevance of these treatments on a case-by-case basis and to limit the doses and durations of prescription. For women over 35 years of age, under Lutéran or Lutényl for at least 5 years or have abnormal symptoms (frequent headaches, disturbances in vision, language, hearing, memory, dizziness, etc), a brain MRI may be prescribed by the doctor. According to the MSNA, 50 to 100, meningiomas per year could be attributed to a use very extended of these treatments.
While these recommendations can be anxiety-provoking for women, currently under Lutéran or Lutényl, sometimes for years, without even having been informed of the risks, the CNGOF (Collège National des Gynécologues et Obstétriciens), in collaboration with the CNEGM (National College of Teachers of Medical Gynecology), wants to reassure and re-assess the balance of benefits and risks of these medicines.
Do not panic in view of the rarity of meningiomas
Dr. Geoffroy Robin, gynecologist and President of the commission and Gynecology Medical of the CNGOF, says outright, ” women under Lutéran or Lutényl should not panic in view of the rarity of meningiomas “. And to continue : “Certainly, these figures can seem high and anxious, but they should be weighted because of the very low annual incidence of meningiomas in the general population : about 8 to 10 cases/100 000 persons per year, or 0.008 to 0.01% of the general population/year ! “To fully understand, the doctor explains, and a figure, very small, multiplied by a high figure, is still very small. “Before demonizing a therapeutic class, it is necessary to put it in perspective, it is rather a new side effect that remains in absolute value very rare. “
In addition, remember that the meningioma is in the vast majority of cases a benign tumor of the brain. “It never implies a treatment by chemotherapy, or the appearance of metastases, reassures the doctor. When you stop the progestin treatment, meningioma, sensitive to progesterone (2/3 of them) will deflate the most of the time, without surgery, and require a “simple” monitoring “. For the 1/3 remaining, there can be no causal link, provides Geoffroy Robin. “If you stop the progestin treatment and that the meningioma does not move, it is that there is no receptor to progesterone so that you can not incriminate the treatment. “
A re-evaluation necessary, case-by-case
On the other hand, this link, as weak as it is, exists and it is necessary, according to the CNGOF take that into account and analyze it to see how patient one can give a treatment, what other it is necessary to propose a monitoring, or even stop it.
In practical terms, the professionals no longer need to renew the treatment, with eyes closed, without question. It is important to reevaluate. Sometimes, in fact, the women have started 20 or 25 years earlier their treatment.
For example, to prevent bleeding in the case of pathologies platelets in women at risk of thrombosis (and therefore who can not take estrogen), there is no other alternative as the progestin. And often, this treatment is prolonged for many years. “As women after 50 years, find themselves still under Lutéran, because they were bleeding young people, and that it has not verified to be menopause if we could stop it, this is not suitable. “
These medicines are also sometimes prescribed (off-label) as contraceptives for women at risk of cardiovascular for which the progestogens are contra-indicated. It is necessary to again re-evaluate.
But, conversely, it is not to demonize the requirements extended, it is always a case-by-case basis, ” continues the doctor. “We must not forget the benefits brought by such medicines to patients and ask what alternatives you can offer ? “Very often,” he observes, “they have been prescribed progestins, because they have contraindications to estrogen, it is already the end of the line…” In addition, it is important to know that these treatments can sometimes ” escape surgeries heavy and psychologically not easy, as the hysterectomy.
Get informed and see her gynecologist
For the time being, “patients should not hesitate to talk to their gynecologists as soon as they look at them again,” advises Geoffroy Robin. And according to the recommendations of the MSNA, ” if they have more than 35 years and that they are taking the treatment for more than five years, request an MRI. “
Of course, the MAN had already sounded the alarm in February 2019, following the identification of cases of meningiomas. Nevertheless, some women were not informed and ask legitimate questions. “It is a message that I personally spend with my patients since the first alert of the MAN a year ago, I open the discussion and I explained to them. To explain, to show the figures, is ultimately reassuring for the patients. This helps put into perspective. “
Progestin and risk of meningioma : a link to better analyze
The MAN has announced that it will enter into ” a phase of consultation in the autumn, with health professionals and patients “.
For the moment, MRI is indicated from the age of 35 from 5 years of use. But this position could be refined in the coming months. The time is now to reassess the balance between benefit and risk. To do this, gynecologists, and medical and midwifery go hand in hand to work on all the indications of macro-progestogens and offer guidance on a case-by-case basis, depending in particular on the available alternatives, and to specify monitoring modalities (MRI) as a function of age, duration of prescription and risk factors. The findings of this re-evaluation will be submitted to the MSNA in September 2020.
The doctor again points out that the increased risk, as early as 6 months of treatment, seems very fast and even ” surprising “, even if it remains in absolute value very low (it goes from a 0.01% risk of meningioma for those who do not take treatment at 0.034 % for users). “According to me, a molecule is not capable of transforming in so short of time a cell of the meninges normal into a tumor cell is benign. This shows that there probably has a promoter effect of the treatment among patients who already have cells ready to be transformed into a meningioma. “According to Geoffroy Robin, it would be interesting to know if there are markers or risk factors that make some women it will have to be more vigilant.
*Study GIS EPIPHARE MSNA-CNAM, made from the data of the health Insurance of more than 3 million women between 2007 and 2018.
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