Measures effective since July 1, 2021
Following data indicating a greater risk of meningioma (brain tumor, most often non-malignant) in women receiving treatment with Lutényl and Lutéran or their generics, the National Medicines Safety Agency (ANSM) has sounded the alarm bell.
Indeed, women whose duration of treatment exceeds 6 months see their risk of meningioma multiplied by 3 compared to women not exposed to these drugs. A risk that increases with the dose used and the duration of treatment. However, this treatment is used in particular against endometriosis, a chronic gynecological disease, which very often requires long-term treatment.
The ANSM has therefore implemented several “safeguard” measures to prevent new cases of meningioma from occurring.
“Doctors prescribing Lutényl, Lutéran or their generics must now give the patients concerned an information document presenting the risk of meningioma associated with these drugs“, announced the Agency in a news item dated July 2.
In addition, “as soon as the treatment is continued beyond one year, any dispensing of these drugs in pharmacies will require to present an annual certificate of information co-signed by the patient and her doctor”, adds the ANSM. It specifies that these new measures are mandatory from July 1, 2021 for treatment initiationand January 1, 2022 for renewals.
Measures taken in consultation with patients and prescribing doctors
In detail, the ANSM distinguishes two main scenarios:
- 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 order “treatment less than one year“;
- For a woman under treatment Lutényl, Lutéran or one of their generics for more than a year, it will be necessary, at the time of the next consultation of gynecology, to discuss the benefit of continuing treatment, taking into account the individual benefit / risk ratio.
For the drug agency, which specifies that these decisions were drawn up in consultation with the patient associations and health professionals concerned, it is a question of patients and doctors weighing together the pros and cons of resorting to these macroprogestogens.
When should a follow-up MRI be performed?
According to the ANSM, a control brain imaging (MRI) should be performed as follows:
- at the start of treatment only in case of meningioma risk factors identified (history of brain radiation therapy in childhood or type 2 neurofibromatosis);
- at any time during or after treatment for signs of meningioma (frequent headaches, dizziness, memory, language, vision or hearing problems, nausea, etc.);
- and after one year of treatment when it needs to be continued.
“If you have been treated for less than a year and you do not experience symptoms suggestive of meningioma, it is not necessary to perform a brain MRI”, however tempers the ANSM.
The information document can be downloaded from the ANSM news update.
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