The risk of brain tumors, also called meningiomas, is confirmed for progestin drugs used in the management of menopause, menstrual disorders and endometriosis, alerted this Thursday the Medicines Agency (ANSM) on the basis of 'a large epidemiological study. This new warning relates to Luteran (chlormadinone acetate) and Lutenyl (nomegestrol acetate) and their generics.
"The risk increases with high doses and long-term treatment," said Jean-Michel Race, director of endocrinology and gynecology drugs at ANSM. Over 400,000 women were taking this treatment in 2019.
A brain envelope tumor
Meningioma is a tumor of the covering of the brain, the vast majority of which is benign. Women treated for more than six months with these molecules (nomegestrol or chlormadinone acetate) are exposed to a risk of developing this tumor multiplied by 3.3 and 3.4 respectively, compared to women not treated with these drugs, according to the study.
The risk is multiplied by 12.5 from 5 years of treatment with Lutenyl and its generics and by 7 from 3.5 years for Lutéran and its generics. Furthermore, 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 aged 25 to 34.
A study on a total of 3.3 million patients
The drug agency had warned in February 2019 of a possible over-risk of meningioma, a tumor of the brain envelopes, the vast majority of which is benign by announcing an epidemiological study to assess it.
This study, which confirms this risk and shows its importance, comes from Epi-flagship, a structure bringing together the ANSM and the Health Insurance. It was carried out using national health insurance reimbursement data on 1.8 and 1.5 million women who took one or the other of these molecules between January 1, 2007 and December 31, 2018.
Their use is already contraindicated in case of existence or history of meningioma. Treatment should be stopped immediately and definitively if this tumor is diagnosed.
Public consultation in autumn 2020
The ANSM issues “preliminary” recommendations at this stage, in particular to inform patients of the risk, and invites them to consult their doctor. The duration of treatment should be limited and at the minimum effective dose, and its merits re-evaluated, she recalls. She also recommends offering women over 35 years of age in case of prolonged treatment (from 5 years), brain imaging by MRI.
In the fall, public consultation between learned societies, professionals and patient associations will be held to take stock and in particular review the relevance of the indications with regard to risk. These drugs are indeed still used for problems of breast tension and premenstrual syndromes. The Lutéran from the Sanofi laboratory will no longer be marketed in France.
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