Following the announcements from the ANSM, which you can find here:
https://www.ansm.sante.fr/Dossiers/Lutenyl-Luteran/Recommandations-d-utilisation-de-Lutenyl-Luteran-et-leurs-generiques-et-de-suivi-des-patientes/(offset)/1
We would like to remind you that the president of the AMAVEA association is a member of the expert committee of the ANSM working group on these two medications.
Her latest report is available here: https://amavea.org/ansm-reunion-du-16-decembre-2020-cst-lutenyl-luteran-et-risque-de-meningiome/
Article of January 12, 2021 Alert on certain progestins here: https://amavea.org/le-monde-12-janvier-2021-lutenyl-et-luteran-madicaments-pour-les-troubles-gynecologique-sont-a-utilisal-avec-precaution-en-raison-risque-de-risqueure
Top health: https://www.topsante.com/medecine/gyneco/endometriose/temoineage-luteran-lutenyl-endometriose-641185
[Testimony] "Luteran is a comfort of today and a risk for tomorrow"
Achievement of endometriosis, Axelle Ayad N'Ciri was treated at Luteran for five years. A medication that "saved his life", while exposing it to a risk of meningioma. She is a member of the scientific committee responsible for reassessing the indications for this treatment.
Axelle Ayad N'Ciri is the voice of women suffering from endometriosis on behalf of the Endomind, as part of the public consultation on the Lutényl and Lutéran treatments and the risk of meningioma. Author of the book Lonely Patient and founder of Mapatho, whose goal is to quickly connect chronically ill patients with the right medical professionals, she shares her own struggle and search for information with Top Santé.
“I started my period very young, before I was even 10. Very quickly, I began to suffer, developing severe acne and being confined to my home by the pain on my periods. At 14, to alleviate the pain, I was put on the pill, without any explanation for my condition. Between 14 and 23, everything was fine. At least, I no longer felt the effects of what I would later learn was endometriosis. Until I decided to change my contraception and use a vaginal ring.”
"Consult a gynecologist, there is something wrong, miss"
At that time, I was 23 years old, and my equilibrium collapsed. The pain returned with a vengeance, to the point that I fainted at work. Rushed to the hospital, a doctor told me I was having an appendicitis attack. But I consulted a second doctor, who refuted this theory: " It's not a gastrointestinal problem, it's gynecological; you should see a doctor, something is wrong."
I went for an X-ray, and the technician told me, " You might have endometriosis." I didn't know what it was; I'd never heard of it, and I didn't know who to turn to. So, I spent three months asking around, and finally, they advised me to go to Cochin Hospital, which has a department specializing in infertility. My doctor, an endometriosis specialist, suggested immediate surgery, a laparoscopy, to remove the adhesions that were blocking my ovaries. I was 23 years old, diagnosed with a disease I knew very little about, and told to expect infertility. But my doctor prescribed medication to take continuouslyand told me I could live my life. So, I went ahead with my plan and moved to China, as expected.
Against endometriosis, two years of luteran
This medication is Lutéran. A hormonal treatment that literally saved my life. I took it continuously between 2013 and 2015. I no longer had my periods, I no longer had abdominal pain, I no longer had any side effects whatsoever. I seemed to be doing well. But this stability didn't last, because after two years, my pain returned and forced me to go back to France for treatment. The adhesions (or lesions) were back, at least as severe as before.
There, the doctors' tune changed drastically: surgery was no longer an option, as it could affect my ability to ever have children. Besides, they told me I should start thinking about having children very soon. At 26, I began fertility treatment. But I was suffering from something else; for some time I'd been experiencing migraines with aura. They also discovered other conditions: polycystic ovaries and hypothyroidism. Each fertility treatment cycle greatly stimulated my ovaries and hormones, and I suffered terribly. So, between attempts (which never worked), I was allowed to restart the medication that gave me my life, Lutéran. I dreamed that fertility treatments would be over so I could be back on that medication and stop suffering.
The impression that my brain is too big for my skull
In 2020, I definitively gave up on IVF and asked my doctor to put me back on continuous Lutéran. My migraines returned with a vengeance; I felt like my brain was too big for my skull. My doctor told me that information was starting to emerge about this medication, that people were questioning its side effects… But at that point, I thought: I had no other way to relieve the endometriosis, and Nurofen helped me cope with the migraines. So I continued. I tried other treatments, but the side effects were terrible: weight gain, debilitating pain, continuous periods, acne… Nothing worked as well as Lutéran. After the diagnostic odyssey, the infertility odyssey, I was now experiencing the medication odyssey.
That said, I'm learning more about this medication, which can cause a meningioma (brain tumor). Benign in the purely medical sense, but certainly not without serious consequences, since it can lead to pain, epilepsy, vision problems… I have to choose between the lesser of two evils: stop everything and let the endometriosis progress, take Lutéran and risk a brain tumor, or choose another treatment with unbearable side effects.
Tomorrow, what solutions for patients?
I represent Endomind within the public consultation on the risks linked to Lotéran and Lentenyl (Editor's note, the ANSM issued new recommendations this January 12). Luteran is comfort today but a huge risk in the future. But what are the alternatives for women who suffer from endometriosis? My goal is to bring the voice of women who take this drug so that they have access to all the necessary information and that they are entitled to a tailor -made medical journey, with regular MRIs to monitor the possible birth of a meningioma. »»
Our time
https://www.notretemps.com/sante/risque-de-meningiome-usage-restreint-fp-202101,i235213
The use of progestinic drugs, which present an over-risk to develop a cerebral tumor -Méningioma-must now be restricted to certain indications, be as short as possible and if not, its merits must be reassessed "at least every year", according to the ANSM drug agency.
These treatments were taken by more than 400,000 women in 2019 for menstrual disorders or menopause and endometriosis.
Meningioma is a tumor of the brain envelopes, the vast majority benign.
Updating the recommendations published Tuesday by the ANSM concerns Lotéran (Chlormadinone acetate) and Lotényl (nomestrol acetate) and their generics as well as the follow -up of the women concerned.
These recommendations, which replace those, provisional, of June 2020, relate in particular to the situations in which the benefit-risk report of these treatments is favorable as well as on the monitoring of patients by brain imaging (MRI exam).
When the alternatives have failed or are contraindicated, these drugs can be prescribed in certain cases such as bleeding linked to pre-operative fibroids or other origins ("functional hemorrhages"), or even anomalies in the breasts ("severe mastopathy").
Luteran generics can also be considered for endometriosis. The treatment must be as short as possible and in the opposite case the benefit-risk report reassessed at least every year.
On the other hand, these treatments, compared to the risk of meningioma, should no longer be prescribed in particular as contraception - "many women took it as a conventional pill" -, or for menopause disorders, notes with AFP Dr Isabelle Yoldjian, head of the ASM gynecological pole. Especially since therapeutic alternatives exist and the risk already increases with age, regardless of any treatment.
Likewise, "the irregularities of the cycle, that is to say when a woman who has cycles not quite regular, or when she has a stomach ache during her period, are indications that we should no longer legitimize," she adds.
With these recommendations, the downward trend in the sale of these drugs should increase, she notes.
According to the update, monitoring by brain imaging examination (MRI) should be carried out regardless of the age of the patient at any time during or after treatment if she has signs evocative of meningiomas (frequent headaches, vision disorders, language, dizziness, etc.) and no longer just from 35 years old. If the treatment is continued, MRIs are planned.
These drugs are already contraindicated in the event of existence or history of meningioma. The treatment must be stopped immediately and definitively in the event of diagnosis of this tumor.
A meeting of the Committee of Experts will be held on January 22 to discuss information documents intended to support these recommendations.
The risk of meningioma, confirmed by a vast epidemiological study published in June 2020, increases with large doses and long -term treatment. A warning on this possible risk had occurred in February 2019 several months after drastic supervision measures for the same reasons towards the Androcur and its generics (active principle: Cyproterone acetate).
The daily newspaper
Genethics
https://www.genethe.org/lutenyl-luteran-et-risque-de-meningiome-lansm-revise-ses-Recommandations/
The French National Agency for Medicines and Health Products Safety (ANSM) has updated its recommendations regarding the use of progestin-only medications . Despite their increased risk of developing a brain tumor, confirmed in June [1] , the health authority did not deem it necessary to withdraw the products . It restricts their use to specific indications [2] , for the shortest possible duration , or at a minimum, with an annual reassessment of the appropriateness of their administration. Prescribing them for contraception, menopause, irregular cycles, or mild breast pain is prohibited. Brain imaging for women taking these progestins for more than a year is no longer age-related.
The two targeted medications are Lutéran (chlormadinone acetate) and Lutényl (nomegestrol acetate), as well as their generic equivalents, which are widely used in France: "In 2019, approximately 200,000 women were taking nomegestrol and 240,000 chlormadinone acetate, representing 80% of prescriptions for these drugs in Europe." Androcur (cyproterone acetate) was also the subject of studies in 2019 and a restriction of its indications (see Contraception and brain tumors: the drug will not be withdrawn from the market ; Androcur, used as a contraceptive, causes brain tumors but continues to be authorized; Androcur: new cases of tumors, legal action). According to Professor Froelich, a neurosurgeon at Lariboisière Hospital in Paris, "all progestins are implicated in meningiomas, to varying degrees." At the Brest University Hospital, in addition to Androcur, Lutényl, and Luteran, the Mirena IUD, Duphaston, Diane 35, and Progestogel have been the subject of pharmacovigilance reports related to the association between meningiomas and progestins. "A study on Mirena has just begun.
The expert committee is scheduled to meet on January 22nd "to discuss the information documents intended to accompany these recommendations." In the 315 testimonies received by the ANSM and made public, the "lack of information" among women "is a recurring theme."
[1] The study published in June 2020[1] shows that "the risk of meningioma for women who have taken these products between six months and ten years is tripled compared to unexposed women." This risk "increases sharply with the cumulative dose, duration, and age of the patient" (see Increased risk of brain tumors linked to taking progestin treatments). It should be noted that the link between progestins and meningiomas "is not new," having already been demonstrated by previous studies.
[2] "When the alternatives have failed or are contraindicated, these drugs can be prescribed in certain cases such as bleeding linked to pre-operative fibroids or other origins (" functional hemorrhages "), or even anomalies in the breasts (" severe mastopathy "). Luteran generics can also be considered for endometriosis. »»
Sources: AFP (12/01/2021); Le Monde, Pascale Santi (12/01/2021)
Yahoo News : HERE
Current woman
In June 2020, a study by the National Medicines Safety Agency (ANSM) revealed the risks of brain tumors associated with the use of luteran and lutenyl, namely progestin drugs. The health authority unveiled new recommendations on these treatments on January 12.
Lutéran and Lutényl are two progestin medications, derived from progesterone. They are indicated for the management of menopause, uterine fibroids, endometriosis , and monthly disorders such as painful periods or irregular cycles.
These medications, which may have been administered as contraceptive pills or acne treatments, may increase the risk of meningioma in women, according to the French National Agency for Medicines and Health Products Safety (ANSM). A meningioma is a brain tumorthat can cause serious problems and may require complex and risky surgery.
In a large epidemiological study published in June 2020, the health authority revealed that women taking one of these progestins for more than six months have approximately 3.3 times the risk of developing a meningioma compared to the baseline risk. The risk is 12.5 times higher for those taking Lutényl for five years. When Lutéran is used for three and a half years, it increases the risk of meningioma sevenfold.
Lutéran and Lotényl: What are the new ANSM recommendations?
Given the "proven increased risk of meningioma associated with taking" Lutényl and Lutéran, the ANSM (French National Agency for Medicines and Health Products Safety) has determined that these medications can no longer be prescribed under the same conditions and has updated its recommendations, which were published on January 12. The authority has decided to restrict certain indications for these progestins and to define the conditions for implementing MRI.
According to the guidelines, Lutényl and Lutéran should no longer be prescribed in cases of menopause, irregular cycles, premenstrual syndrome, non-severe mastodynia and contraception because for these situations, the "benefit/risk ratio is considered unfavorable", the authority stated.
However, these medications may be administered in cases of functional bleeding, menorrhagia related to fibroids in the pre-operative period, severe breast disease, and endometriosis because the benefit/risk ratio is "favorable." But this will only be possible for "women of childbearing age when therapeutic alternatives have failed or are contraindicated." The ANSM (French National Agency for Medicines and Health Products Safety) has specified that, in this case, the treatment must be as short as possible and that the benefit/risk ratio must be reassessed at least once a year.
The agency also recommends that all women taking these two progestins undergo an MRI , regardless of age. This examination should be performed during or after treatment if symptoms suggestive of meningiomas occur. The examination is recommended after one year of treatment if it needs to be continued, then five years after the first MRI, and then every two years as long as treatment is ongoing. The agency further specified that an MRI should also be performed "at the start of treatment if identified risk factors for meningioma are present."
What to do if we take or if we were treated with lutenyl and luteran?
The ANSM (French National Agency for Medicines and Health Products Safety) has urged women who are taking or have taken these progestins to be attentive to signs suggestive of a meningioma, namely frequent headaches , vision problems , speech difficulties, or memory problems, and to discuss their management with their doctor. "Together, you may need to adjust your treatment and/or arrange for brain imaging monitoring, depending on your situation," the agency's press release states.
- In June 2020, an epidemiological study revealed an overview of developing meningioma for women treated in Lotéran and Lotényl, two progestin pills used by around 600,000 women in France.
- In September, the ANSM launched a public consultation and organized public hearings of patients to see in which cases these treatments were prescribed.
- 20 Minutes retraces these few months of health democracy by giving the floor to the head of the gynecology unit of the ANSM and to one of the patients interviewed.
The investigation took six months, but the recommendations are likely to significantly change their use. After warning as early as June 2020 about the risk of meningioma (most often a benign brain tumor) for women taking Lutéran (whose active molecule is chlormadinone acetate) and Lutényl (nomegestrol acetate), two very common progestin drugs, the National Agency for the Safety of Medicines and Health Products (ANSM) is unveiling its new recommendations this Tuesday.
Meanwhile, the agency has requested caregivers, patient associations, researchers and women concerned to stick as close as possible to the field.
What indications and what follow -up?
As a result, the ANSM (French National Agency for Medicines and Health Products Safety) has significantly restricted the indications for these pills. They should no longer be prescribed in cases of menopause, menstrual irregularities, premenstrual syndrome, mild mastodynia (breast pain), or for contraception. However, the benefit-risk balance was deemed favorable in cases ofendometriosis, functional bleeding, menorrhagia (very heavy periods) related to fibroids , and severe mastopathy (non-cancerous breast disease).
“For Lutéran and Lutényl, the marketing authorizations (MAs) date from 1973 and 1984 respectively,” explains Isabelle Yoldjian, head of the gynecology department at ANSM. “However, they are used extensively, often with a significant deviation from the wording of the MAs. It was important to clarify these indications.”
How many women would be affected? The work of the ANSM did not make it possible to obtain exhaustive figures, but "we know that in 2019, around 200,000 women had taken lutenyl (or generics) at least once and 240,000 of the luteran (or generic). Suffice to say that these new recommendations, if they are followed, may drop sales. "Between August 2018 and August 2020, there is a decrease in prescriptions of 30 % for the Lotényl and 50 % for the Lotéran," says Isabelle Yoldjian.
The second issue is: what will the follow-up be for patients? Here again, the recommendations deviate significantly from what was previously the case. "In June, we recommended magnetic resonance imaging (MRI) starting at age 35.Now, we've removed the age limit," she emphasizes. "All women must have a brain MRI after one year of treatment." The patient is then encouraged to have another MRI five years after the first scan, and then every two years thereafter.
Why this acceleration? "If you take treatment for three or four years, the risk is less than eight years," says Isabelle Yoldjian. The longer you are treated, the more close surveillance it takes. And of course, all patients must carry out this examination at any time during or after treatment in the event of signs evocative of meningiomas (headache, language disorder, vision, memory, paralysis, dizziness).
"It was presented to me as the miracle solution"
To avoid overlooking an important issue, patients were given the opportunity to share their opinions on these treatments over the past few months. This was done through a call for testimonials (which received 500 contributions) and six public hearings with patients from diverse backgrounds. Véronique, 30, was one of the patients consulted. After being diagnosed with endometriosis at 28 and suffering terribly, she took Lutéran for nine months, then Lutényl for a year. "It was presented to me as a miracle cure," she explains. "And it's true that it helped with the pain. But the side effects were very significant: acne, weight gain, depressive symptoms..." In June 2020, following the ANSM's (French National Agency for Medicines and Health Products Safety) alert, her surgeon advised her to stop immediately. "It's a shame to think that doctors and researchers were aware of the risks, and that I only learned about them through the press," she laments. So when the Endofrance warned that the ANSM was looking for testimonies, it offered itself.
"I am not saying that all women experience Luteran badly, but it was my case. I was so sensitive that I could cry if someone did not pass me salt at the table! When I complained of having taken 12 kg, I was told that I may have ate too much? On November 2, during public hearings (in Visio, Cavid-19 obliges), Véronique was unable to listen to all the testimonies, "so they (l) 'destabilized. Some stories are dramatic. One of the patients had undergone invasive brain surgeries. All that to better live menopause… ”
Not "a banal pill"
The patients' accounts held a few surprises for the committee experts, particularly regarding the use of these treatments as contraception. " Following the publication of the first article in 20 Minutes, many women responded to our call for testimonials and thought their treatment was just a regular birth control pill," Isabelle Yoldjian noted with surprise. "The public hearings proved particularly interesting on this point."
Hence the watchword that the agency wishes to pass: "In contraception, there is no need to authorize this treatment insofar as there are alternatives," she insists. Likewise for menopause. “The risk of meningioma increases with age. We therefore come up against a very important impact if we combine this risk with the use of a drug that gives meningiomas. The second thing that has come back from hearings is the lack of information available to women. Health professionals are not aware or do not transmit information, which is recent, it is true. These testimonies encouraged us to email healthcare professionals in November ”.
How to improve information to patients?
The agency plans to go further. A final committee meeting is scheduled for January 22nd to determine how healthcare professionals and women can access accurate information. For Androcur( another progestin that was the subject of a public consultation), the agency implemented a certification process: when prescribing the medication, both the healthcare professional and the patient had to sign a document stating that the patient was aware of the risks involved. This certification is mandatory for purchasing Androcur. Will this be the case? The question remains to be decided. "What we do know is that an information letter will be sent to all patients receiving Lutéran and Lutényl," reveals Isabelle Yoldjian.
Véronique hopes that this public consultation will allow "to inform patients much better. Most of the testimonies I heard mentioned this lack of alert. We often advance the question of profit/risk, but we can only hear about it in a gynecologist! And beyond these progestogens, it would be necessary to pay attention to the patient's information when it is given a new treatment. »»
Risk of brain tumor: Lotényl and Lutéran in the viewfinder of the Medicines Agency
The medication gendarme has issued new recommendations on the use of Lotéran and Lotényl, two drugs that are very common.
By Maxime François on January 18, 2021 at 8:48 a.m., modified on January 19, 2021 at 06:27
Warning about the medications Lutényl (nomegestrol acetate), Lutéran (chlormadinone acetate), and their generic equivalents—progesterone derivatives—intended for gynecological disorders! They should be used with extreme caution due to the increased risk of brain tumors they may cause, warns the French National Agency for Medicines and Health Products Safety (ANSM) after conducting a large-scale investigation into these treatments intended for menstrual disorders, menopause, perimenopause, endometriosis, and, less frequently, as contraceptives. The issue is critical: in 2019 alone, nearly 400,000 women used these medications.
From now on, their use must be restricted to specific indications and be as short as possible. Otherwise, their consumption must be reassessed "at least every year" because "the risk increases sharply with the cumulative dose, the duration and age of the patient", specifies the study. It is even multiplied by 12.5 from five years of treatment under Lotényl, and by 7 after three and a half years under Lutéran.
This study involved 1.8 million women who took nomegestrol acetate and 1.5 million who took chlormadinone acetate, between January 1, 2007 and December 31, 2018. In total, "more than 1000 meningiomas (Editor's note: tumors of the membranes of the brain, the vast majority of which are benign) operated on are attributable to these two molecules between 2007 and 2018, or about 100 cases per year," revealed epidemiologist Alain Weill, deputy director of Epi-phare, who led the study.
Follow -up by MRI
In light of these new results, the ANSM has issued new recommendations, including the monitoring of patients by brain imaging (MRI). These examinations must be carried out regardless of the patient's age "at any time during or after treatment in case of signs suggestive of meningiomas ", "after one year of treatment when it needs to be continued, then five years after the first MRI, then every two years as long as the treatment is continued" but also in case of "identified risk factors", warns the ANSM.
The latter specifies that for women in a situation of "menopause, artificial cycle in association with an estrogen, cycle irregularities, premenstrual syndrome, non-severe mastodynia or contraception (without factor of associated cardiovascular risk)", "benefit-risk is considered unfavorable" and we must not use these treatments.
When therapeutic alternatives have "failed" or are "contraindicated," the "benefit-risk ratio is considered favorable" for the use of Lutényl for women experiencing "functional bleeding, preoperative fibroid-related menorrhagia, or severe breast disease," the Agency states. For Lutéran, the criteria are similar, but the ASNM specifies that the use of this treatment is also "favorable" for women with endometriosis. Newsletter: The essentials of the morning. A roundup of the news to start the day.
These recommendations follow a previous study conducted by the ANSM and published in June. That study already established a significantly increased risk of meningioma in women taking these treatments. An expert committee is scheduled to meet on January 22nd to discuss the information documents intended to accompany these recommendations.
