The two progestin treatments Lotényl and Lotéran are well associated with an increased risk of meningioma, a kind of brain tumor, confirms the drug agency. It therefore confirms their restrictions on use.

Two progestin treatments, the same risk of brain tumor. Lotényl and Luteran are well associated with an increased risk of meningiomas , confirms on April 20 the National Medicines Safety Agency ( ANSM ), which pharmaco-epidemiological reports on April 20

A strong association, which depends on the dose

These reports are based on two observational studies conducted by the Scientific Interest Group (GIS) EPI-Phare . In both cases, these studies conclude that a strong association, dependent on the dose, between the prolonged use of nomestrol (lutenyl and generic) acetate and chlormadinone (luteran and generic) acetate and the risk of meningiomas.

If meningiomas are generally non -cancerous tumors , they use certain areas of the brain and most often require risky surgery for the patient.

Studies also confirm that risk reduction is notable after stopping treatment.

18.5 cases per 100,000 people with Lotéran

In detail, the results obtained on these two molecules are comparable. For Lotéran, experts analyzed data from 1,057,392 women aged 10 to 70 living in France who started processing between 2007 and 2017. They were classified into two groups, “exposed” or “very slightly exposed”, according to the doses they received.

In the “Exposed” group, the incidence of meningioma was 18.5 per 100,000 people per year, against 6.8 per 100,000 people per year in the “very slightly exposed” group.

19.3 with the Lotényl

For Lotényl, experts relied on the data of 1,060,779 women aged 10 to 70 living in France who started processing between 2007 and 2017.

The “Exposed” group presented an incidence of 19.3 cases of meningioma per 100,000 people per year, against 7.0 per 100,000 in the “very slightly exposed” group.

The biological mechanism still unknown

In these two reports, the experts observe that “ the meningiomas located in the previous and average part of the skull base were particularly associated with prolonged exposure ” with one or the other of these molecules.

For these scientists, " all the elements characterize a relationship of a causal nature even if the underlying biological mechanism is not yet completely known" .

Brain MRI surveillance

While waiting to understand this mechanism, the ANSM confirms its recommendations issued in January 2021: to restrict the indications for these treatments to only cases of disabling breast pain, endometriosis and hemorrhages linked to uterine fibroids .

For these three situations, “ the treatment must be as short as possible and the benefit/risk ratio must be reassessed at least once a year ” then cut the ANSM. And for women under treatment, regular monitoring by brain MRI should also be implemented.

Lotényl and Luteran should no longer be used against menopause disorders , against the irregularities of the menstrual cycle or premenstrual syndromes , against pain of non -severe breasts or as contraception.

In 2019, these two progestin treatments were taken by more than 400,000 women in France to relieve menstrual disorders or menopause symptoms.

Link to the article here: https://www.allodocteurs.fr/se-soigner/medicaments/lutenyl-et-luteran-deux-etudes-confirment-les-risques-de-tumeur_31108.html