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 sur-risk demonstrated by meningioma associated with the taking of nomestrol ( Lotényl® Lutéran® acetate , the National Medicines Agency (ANSM) announced on January 12 to restrict their indications. From July 1 , the agency indicates in a press release that the prescribing doctors of these two drugs or their generics must give the patients an information document presenting the risk of meningioma. Furthermore, as soon as the treatment is continued beyond one year, any dispensation of these pharmacy drugs will require an annual information certificate co-signed by the patient and her doctor . These new measures are compulsory as of July 1, 2021 for treatment initiations and January 1, 2022 for renewals . associated with these drugs. After a first warning in February 2019, the drug agency again alerted the risk of meningioma associated with the use of these treatments, and their generics in June 2020.
What is Lotéran and Lotényl?
Lutéran® and Lotényl® are progestin drugs reserved for women . A progestin is a hormone secreted naturally in the middle of the menstrual cycle of women. It promotes the implantation of the egg in the uterus so pregnancy. But taken during the 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 progestogens or hormonal IUDs . Used alone or coupled with estrogen, it behaves like a contraceptive . Lutéran® and Lotényl® can be indicated during irregularities in the menstrual cycle, disorders preceding painful rules and rules, breast pain , artificial cycle in combination with estrogen, endometriosis , 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?
Meningioma is a tumor , most often benign, which develops from the membranes that wrap the brain and the spinal cord (the meninges). In June 2020, the EPI-Phare study, made up of the ANSM and the CNAM, confirmed the on-risk of meningioma in women exposed to these macroprogestative drugs, and highlighted a significant increase in the risk with the dose used, the duration of treatment and the age of the patient .
→ Women treated more than 6 months by Nomestrol or Chlormadinone acetate are exposed to a multiplied risk respectively by 3.3 and 3.4 compared to the basic risk, then by 12.5 from a cumulative dose corresponding to 5 years of treatment for nomigestrol acetate and 7 from a cumulative dose corresponding to 3.5 years of use of acetate Chlormadinone.
→ 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 the therapeutic alternatives have failed or are contraindicated:
- Endometriosis
- Functional hemorrhages
- Menorrhagia related to pre-operative fibroids
- Severe mastopathy.
> The risk profit for treatment will be reassessed at least every year . The treatment should be as short as possible.
For Lotényl® and generics: in women of procurement, in the following situations, when the 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?
As soon as the treatment is continued beyond one year, any dispensation of these pharmacy drugs requires presenting an annual information certificate co-signed by the patient and her doctor. This measure is compulsory from July 1, 2021 for initiations of treatment and 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 "processing less than one year" from July 1, 2021 .
- Information certificate is not essential during the first year of processing.
- The patient can obtain her medication at the pharmacy only if this mention appears 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.
- At the latest on January 1, 2022 , the doctor will have to give the patient the information document and a copy of the co-signed information certificate (the original is kept in the patient's medical file). The certificate must be presented to obtain the drug in pharmacy.
Please note : whatever the age of treatment, it must be reassessed at each gynecology consultation and at least once a year. If your treatment ensured your contraception, in the event of a stop, even punctual, you should think about using 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 , artificial cycle in association with 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 evocative of meningioma (frequent headache, vision, language or hearing disorders, dizziness, memory disorders, etc.) and consult your doctor as soon as possible.
- 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.
