Risk of confirmed brain tumors for progestogy drugs- Ouest France
Luteran, lutenyl and their generics, drugs used in the management of menopause, menstrual disorders and endometriosis, would increase the risk of meningiomas, according to a study published on Wednesday.
https://www.ouest-france.fr/sante/risque-de-tumeurs-cerebrales-confirme-pour-des-medicaments-progestififies-6871884
The risk of brain tumors - meningiomas - is confirmed for drugs used in the management of menopause, menstrual disorders and endometriosis, alerts the drug agency (ANSM) on the basis of a large epidemiological study published this Wednesday, June 17, 2020.
This new warning concerns luteran (chlormadinone acetate) and lutenyl (nomestrol acetate) and their generics.
The risk increases with the high doses and a long-term treatment
, underlines Jean-Michel Race, director of endocrinology and gynecology drugs at the ANSM.
More than 400,000 women took this treatment in 2019.
Meningioma is a tumor of the brain envelopes, the vast majority benign.
Data on 1.8 and 1.5 million women
Women treated for more than six months by these molecules (nomigestrol 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 Lotényl and its generics and 7 from 3.5 years for Lotéran and its generics.
In addition, the risk of meningioma leading to intracranial surgery increases sharply with age: it is, for example, three times higher for women aged 35 to 44 than for those from 25 to 34 years.
The medication agency had warned in February 2019 of a possible over-risk of meningioma, a tumor of the brain envelopes, the vast majority benign by announcing an epidemiological study to assess it.
This study, which confirms this risk, and shows its importance, comes from Epi-Phare, a structure bringing together ANSM and health insurance. It was made from national data for reimbursement of health insurance on 1.8 and 1.5 million women who took one or other of these molecules between January 1, 2007 and December 31, 2018.
MRI recommended for women over 35 in the event of prolonged treatment
Their use is already contraindicated in the event of existence or history of meningioma. The treatment must be stopped immediately and definitively in the event of diagnosis of this tumor.
preliminary
recommendations at this stage, in particular to inform patients of the risk, and are suitable for consulting their doctor. The duration of treatment must be limited and at the minimum dose effective, and its re-evaluated property, she recalls.
She also advocates to offer women over 35 in the event of prolonged treatment (from 5 years old), brain imaging by MRI.
In the fall, public consultation between learned companies, professionals and patient associations will be held to take stock and in particular to review the relevance of the indications with regard to the risk.
These drugs are still used for problems of breast tensions and premenstrual syndromes.
The Lotéran of the Sanofi Laboratory will soon be marketed in France
Risk of confirmed brain tumors for progestogy drugs- Ouest France
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