Lotényl / Lotéran: documents to guarantee the information of women on the increase in the risk of meningioma
Lutényl prescribing doctors (Nomestrol acetate), Lutéran (Chlormadinone Acetate) or their generics must now give the patients concerned an information document presenting the risk of meningioma associated with these drugs.
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.
These documents were developed in consultation with patient associations and relevant healthcare professionals. Their aim is to better inform women about the risk of meningioma and to facilitate discussion between the patient and her doctor during medical consultations, so that they can jointly decide whether or not to use these medications.
The information document also specifies the imaging follow-up procedures to be carried out during treatment, as well as the steps to take in the event of a meningioma diagnosis.
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.
You can also download them (see below).
In addition, paper copies of these information documents will be sent out during the second half of July.
Magazines report new rules and documents, such as Sante Magazine
https://www.santemagazine.fr/actualites/actualites-sante/lutenyl-luteran-et-meningiome-lansm-detaille-les-nouvelles-conditions-et-de-delivrance-de-ces-progestifs-894796
Lutenyl, Luteran and Meningioma: ANSM details the new conditions and delivery of these progestins
Following the discovery of cases of meningioma due to two commonly prescribed progestins, in particular against endometriosis, the drug agency has unveiled new measures to limit the risks for patients.
Effective measures since July 1, 2021
Following data indicating a risk of meningioma (cerebral tumor, most often non -malignant) in women receiving treatment based on Lotényl and Luteran or their generics, the National Medicines Safety Agency (ANSM) sounded alarm.
Indeed, women whose treatment lasts more than six months have a threefold increased risk of meningioma compared to women not exposed to these medications. This risk increases with the dose used and the duration of treatment. This treatment is notably used to treatendometriosis, a chronic gynecological disease that often requires long-term management.
The ANSM has therefore implemented several measures, "safe", to prevent new cases of meningioma from occurring.
"Doctors prescribing Lutényl, Lutéran or their generics must now provide patients concerned with an information document outlining the risk of meningioma associated with these drugs," the Agency announced in a news item dated July 2.
Furthermore, "once treatment is continued beyond one year, any dispensing of these medications by pharmacy will require the presentation of an annual information certificate co-signed by the patient and her doctor," adds the ANSM. It specifies that these new measures are mandatory from July 1, 2021 for new treatmentsand from January 1, 2022 for renewals.
Measures taken in consultation with patients and prescribing doctors
In detail, the ANSM distinguishes two large cases:
- For a woman starting treatment with Lutényl, Lutéran or one of their generics, or a woman treated for less than a year: since July 1, 2021, the doctor must give the patient the information document and mention on the prescription " treatment less than one year ";
- For a woman who has been taking Lutényl, Lutéran or one of their generics for more than a year, it will be necessary, at the next gynecological consultation, to discuss the benefit of continuing the treatment, taking into account the individual benefit/risk ratio.
For the Medicines Agency, which specifies that these decisions have been developed in consultation with the associations of patients and the health professionals concerned, it is that patients and doctors weigh together the pros and cons to use these macroprogestatives.
When should you make a control MRI?
According to the ANSM, brain imaging (MRI) of control must be carried out as follows:
- at the start of treatment only in the case of identified risk factors for meningioma (history of brain radiotherapy in childhood or neurofibromatosis type 2);
- at any time during or after treatment in case of signs suggestive of meningiomas (frequent headaches, dizziness, memory, speech, vision or hearing problems, nausea…);
- And after a year of treatment when it requires being prosecuted.
" If you have been treated for less than a year and do not experience symptoms suggestive of meningioma, it is not necessary to have a brain MRI," the ANSM cautions.
The information document can be downloaded from the ANSM news item.
