The National Medicines Safety Agency (ANSM) has published a warning concerning two treatments: Luteran (chlormadinone acetate) and Lutenyl (nomegestrol acetate). This warning also applies to their generic versions. In a press release dated June 17, the ANSM alerted “again” health professionals and women to the risk of meningioma associated with the use of nomegestrol acetate (Lutenyl and generics) and acetate. chlormadinone (Lutéran and generics). Meningioma is a tumor, most often benign, that develops from the membranes that surround the brain and spinal cord (the meninges). On the basis of an epidemiological study carried out on a very large number of patients by the scientific interest group (GIS) EPI-Phare and confirming this over-risk, a scientific committee of the ANSM issued preliminary recommendations for use and monitoring, pending a consultation phase which will be organized in the fall, in particular with health professionals and patients. In detail, the PPE-Phare study explains that “women treated for more than six months with nomegestrol acetate or chlormadinone are exposed to a risk multiplied by 3.3 and 3.4 respectively compared to the basic risk , then by 12.5 from a cumulative dose corresponding to 5 years of treatment for nomegestrol acetate and by seven from a cumulative dose corresponding to 3.5 years of use of chlormadinone acetate . Furthermore, 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 aged 25 to 34 ”. The recommendations concern caregivers on the one hand and patients on the other. People who are currently being treated “with nomegestrol acetate (Lutenyl and generics) or chlormadinone acetate (Luteran and generics)” are invited to consult their doctor to discuss their management.
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