The Medicines Agency (ANSM) is launching a public consultation on the conditions of use for women of these progestin treatments with regard to the risks of meningioma.
Diane 35 rd and 4th generation pills , Androcur ... After repeated scandals in recent years, the health authorities are increasingly cautious about the risks associated with contraceptive pills and hormonal treatments in general.
Lotényl (Nomestrol acetate), Lotéran (Chlormadinone acetate) and their generics to be in the sight of the National Medicines Agency ( ANSM ) . The latter published in June 2020 a warning and recommendations concerning these treatments presenting a risk of developing meningioma.
This time she appeals to participate, until September 30, 2020 , in a public consultation to encourage healthcare professionals, patients and associations to discuss together the best use of these treatments.
Prescribed in the treatment of menopause and endometriosis
Chlormadinone acetate and Nomestrol acetate, the molecules present respectively in Luteran and Lytényl, are progesterone derivatives used in particular in the management of menopause , menstrual disorders and endometriosis . The drug agency estimates that between 500,000 and 600,000 women take one of these drugs .
cases , a tumor in the most often benign brain , were reported when using these drugs in therapeutic doses. "In addition, the survey on Androcur two years ago had updated an over-risk of meningioma, it was therefore logical to take an interest in its cousins, two other macro -rogestatives," said the ANSM, contacted by Actu.fr.
An epidemiological study more advanced with three million women (1) was therefore conducted and confirmed in early June the sur-risk of meningioma associated with the taking of Lotéran, Lotényl and their generics.
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Up to 12.5 times more risk of tumor
As for most side effects specific to any medication, the risk is higher or lower depending on the dosage, duration of treatment and age of the patient.
Concretely, a woman who takes lutenyl or luteran more than six months is at risk approximately 3.3 times more to develop a meningioma than a woman who does not take it. From the age of five, the risk is multiplied by 12.5 for the Lotényl, and by 7 from 3 and a half under Lutéran.
In addition, the risk of meningioma leading to intracranial surgery increases sharply with age : it is for example 3 times higher for women aged 35 to 44 than for those from 25 to 34 years old, the ANSM indicates in a note .
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Measure the benefit/risk balance
If it is not a question of withdrawing these drugs from the market -it should be noted that Lotéran has not been marketed since September, the Sanofi laboratory having stopped its production for a reason independent of this alert -, the consultation launched by the ANSM aims to reflect on a better use of these treatments:
The objective is to reach a fair level of prescription, a benefit/risk balance for each patient and find alternatives to these drugs when possible and necessary.
In 2018, the alerts launched on the Androcur had made it possible to largely reduce its prescription : from 90,000 in September 2018, the number of patients treated before ANSM communications increased to 11,000 in 2020. "With Androcur there was a lot of prescription outside the marketing authorization [acting against hirsutism and endometriosis, this treatment was often also prescribed against acne or in a single contraceptive pill , ", Underlines the health agency.
With the Lotéran and the Lotényl we are on a wider exhibition of women but we could also manage to stop their prescription as a contraceptive when it does not have to be, for example.
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Do not panic patients
"Nor should the patients panic," says Yasmine Candau, president of Endofrance . The National Association for the Fight against Endometriosis was associated from the start with the follow -up of work on these progestins to relay prevention messages from its 2,300 members and 22,000 sympathizers.
Recommendations to doctors and patients taking these treatments, in order to discuss their relevance and the possibility of finding an alternative / or taking treatment for more than 5 years.
“Most of our members or sympathizers have confirmed that their doctor had contacted them on this subject. This has decreased anxieties because a meningioma, even if it is often benign , it scares, ”confirms Yasmine Candau, who adds:
But some were also very anxious at the idea of having to stop their treatment. Many prefer to continue it by accepting the risk because they feel too well with it. You should know that even if alternatives exist, it often takes months for the body to get used to a new medication.
The round table with all those who have expressed the wish to participate will be held on November 2 and will be broadcast live on the ANSM Youtube channel . An assessment of exchanges will be drawn up in the following days.
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(1) Study by the Scientific Interest Group (GIS) EPI-Phare and carried out from national data for reimbursement of health insurance on 1.8 and 1.5 million women who consumed nomestrol or chlormaudinone acetate between January 1, 2007 and December 31, 2018.
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