Faced with the demonstrated over-risk of meningioma (brain tumor) in women taking luteran or lutenyl or their generics, these progestin drugs can no longer be prescribed under the same conditions. New indications, prescription conditions and contraindications.
Given the demonstrated increased risk of meningioma associated with taking nomegestrol acetate (Lutényl® and generics) and chlormadinone acetate (Lutéran® and generics), the French National Agency for Medicines and Health Products Safety (ANSM) announced on January 12th that it would restrict their indications. As of July 1st, the agency stated in a press release that physicians prescribing these two medications or their generic equivalents must provide patients with an information document outlining the risk of meningioma. Furthermore, if treatment continues beyond one year, any dispensing of these medications at a pharmacy will require an annual information certificate co-signed by the patient and her physician. These new measures are mandatory from July 1st, 2021 for new prescriptions and from January 1st, 2022 for renewalsassociated with these medications. After an initial warning in February 2019, the Medicines Agency again alerted the public to the risk of meningioma associated with the use of these treatments, and their generics, in June 2020.
What is Lotéran and Lotényl?
Lutéran® and Lutényl® are progestin-only medications for women . A progestin is a hormone naturally secreted in the middle of a woman's menstrual cycle. It promotes implantation of the fertilized egg in the uterus, thus facilitating pregnancy. However, when taken during the menstrual cycle, it has the opposite effect. It thickens the uterine walls, which can no longer receive the egg. This is why this substance is used in the manufacture of progestin-only pills or hormonal IUDs. Used alone or in combination with estrogen, it acts as a contraceptive . Lutéran® and Lutényl® may be indicated for menstrual irregularities, premenstrual disorders and painful periods, breast pain , artificial cycles in combination with estrogen, endometriosis , and bleeding related to fibroids .
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> See the Luteran medication sheet
> See the medication file Lutényl
Lotéran, Lotényl: Who are women at risk of meningioma?
A meningioma is a tumor, most often benign, that develops from the membranes surrounding the brain and spinal cord (the meninges). In June 2020, the EPI-PHARE study, conducted by the ANSM and the Cnam, confirmed the increased risk of meningioma in women exposed to these macroprogestin drugs, and highlighted a significant increase in risk with the dose used, the duration of treatment, and the patient's age.
→ Women treated for more than 6 months with nomegestrol acetate or chlormadinone acetate are exposed to a risk multiplied by 3.3 and 3.4 respectively compared to the baseline risk, then by 12.5 from a cumulative dose corresponding to 5 years of treatment for nomegestrol acetate and by 7 from a cumulative dose corresponding to 3.5 years of use of chlormadinone acetate.
→ The risk of meningioma leading to intracranial surgery increases sharply with age : it is 3 times higher for women aged 35 to 44 than for those aged 25 to 34.
What are the new indications?
As of January 12, 2021, for Lutéran® and generics: In women of childbearing age, in the following situations, when therapeutic alternatives have failed or are contraindicated:
- Endometriosis
- Functional hemorrhages
- Menorrhagia related to pre-operative fibroids
- Severe mastopathy.
The benefit-risk ratio of the treatment will be reassessed at least annually. The treatment should be as short as possible.
For Lutényl® and generics: In women of childbearing age, in the following situations, when therapeutic alternatives have failed or are contraindicated:
- Functional hemorrhages
- Menorrhagia related to pre-operative fibroids
- Severe mastopathy.
> The risk of treatment will be reassessed at least every year. The treatment should be as short as possible ”
Whatever the age of treatment, it must be reassessed at each gynecology consultation and at least once a year.
What is the necessary information certificate in pharmacy?
Once treatment continues beyond one year, any dispensing of these medications by pharmacy requires the presentation of an annual information certificate co-signed by the patient and her doctor. This measure is mandatory from July 1, 2021 for new treatments and from January 1, 2022 for renewals.
For a beginner woman a treatment with Lotényl, Lotéran or one of their generics or a woman treated for less than a year :
- The doctor must give the patient the information document and mention on the prescription "treatment less than one year" from July 1, 2021.
- Information certificate is not essential during the first year of processing.
- The patient will only be able to obtain her medication at the pharmacy if this is indicated on her prescription.
For a woman under treatment Lutényl, Lotéran or one of their generics for more than a year :
- On the occasion of the next gynecology consultation, the interest in continuing treatment must be reassessed taking into account the individual benefit/risk ratio.
- By January 1, 2022, at the latest, the doctor must provide the patient with the information document and a copy of the co-signed information certificate (the original is kept in the patient's medical file). This certificate must be presented to obtain the medication from the pharmacy.
Important : Regardless of how long you have been taking this medication, it must be reassessed at each gynecological appointment and at least once a year. If your medication provided contraception, if you stop taking it, even temporarily, you must use an effective contraceptive method.
What are the contraindications?
As of January 12, 2021, the use of these two progestins is to be avoided due to a profit/risk considered as unfavorable and therapeutic alternatives available in the following cases:
- Menopause, an artificial cycle in association with an estrogen
- Cycle irregularities
- Premenstrual syndrome (essential dysmenorrhea)
- Non -severe mastodynia
- Contraception (without associated cardiovascular risk factor).
Be attentive to symptoms evocative of a meningioma: frequent headache, vision, language or hearing disorders, dizziness, memory disorders ...
When to do a control MRI?
Magnetic resonance imaging (MRI) is the only examination capable of detecting small meningiomas. It must be carried out regardless of the age of the patient:
- at any time during or after treatment in the event of signs evocative of meningiomas;
- after 1 year of treatment when the treatment requires being continued, then 5 years after the first MRI, then every 2 years as long as the treatment is continued;
- to the initiation of treatment in the event of identified risk factors of meningioma (history of encephalic radiotherapy in childhood or neurofibromatosis of type 2).
What advice if we take it?
If you are or have been treated by Lotényl® or Lotéran® or their generics, the ANSM recommends :
- Discuss your care with your doctor during a next gynecology consultation: with regard to the new recommendations for use and follow -up, you may be brought together to develop your treatment and/or to set up monitoring by brain imaging according to your situation;
- Symptoms. Be attentive to symptoms suggestive of a meningioma (frequent headaches, vision, speech or hearing problems, dizziness, memory problems…) and consult your doctor as soon as possible if you experience any symptoms.
- If your treatment ensured your contraception, in the event of a stop, even punctual, you should think about using an effective contraceptive method.
Sources:
Lutényl / Lotéran: Documents to guarantee the information of women on the increase in the risk of meningioma. ANSM. 07/02/2021
Nomestrol (lutenyl and generic) /chlormaudinone (luteran and generic) acetate, and risk of meningiom: recommendations for using and monitoring patients. Information point of January 12, 2021. ANSM.
Ansm press release, Lutényl/Lotéran and risk of meningioma: call for participation for a public consultation - Information point, September 10, 2020.
