This warning comes several months after drastic measures taken for the same reasons for a first drug, Androcur (Bayer laboratory) and its generic drugs (active ingredient: cyproterone acetate).
Luteran and Lutenyl
The medicines involved in this new warning are Luteran (Chlormadinone acetate) and Lutenyl (nomegestrol acetate), as well as their generic medicines. Meningiomas have been associated with their use. These drugs, sold by nine laboratories, are derivatives of a hormone, progesterone.
However, and unlike Androcur, these reported cases of tumorsdo not conclude at this stage that women who use these drugs have a higher risk of meningiomas than the women in the general population", Adds the ANSM to an information point that is available online.
There is a study in progress
In order to determine whether the use of these two progestogens is associated with a risk of developing a meningioma, an epidemiological study will be carried out in the coming months by experts from Epi-Phare, a public expertise structure that is the Medicines Agency and health insurance. At the same time, a pharmacovigilance study is under way to better characterize this risk, according to the ANSM.
The care office wrote in anticipation of the resultsnew recommendationsHealth professionals (endocrinologists, gynecologists, generalists, pharmacists, neurologists, neurosurgeons) The use of these molecules – chlormadinone acetate or nomegestrol acetate – "is contraindicated in case of existence or a history of meningioma," she says. In the case of diagnosis of meningiomas, treatment with these active ingredients should be "stopped immediately and definitively" and the action to be taken with a neurosurgeon should be discussed.