Question 25718 — pharmacy and medications

Summary

Mr. Fabrice Le Vigoureux draws the attention of the Minister of Solidarity and Health to the serious consequences of taking cyproterone acetone (Androcur) in women suffering from hormonal imbalance. A study carried out by the National Medicines Safety Agency (ANSM) estimated the number of women affected by a meningioma (benign brain tumor) following taking Androcur between 2007 and 2015 at 500. This figure does not hold true. account of women operated on during this period. The real number of women concerned would therefore be closer to a thousand. Furthermore, a warning concerning the risks associated with taking this medication was issued in 2008 and special monitoring was decided in 2009 by the European Medicines Agency (EMA). Despite this, Androcur continued to be prescribed to patients on a long-term basis. In 2018, the ANSM and the CNAM formed the Epi-Phare scientific interest group (GIS) whose mission is to coordinate and carry out pharmaco-epidemiology studies with the aim of informing public authorities in their decision-making and responding to the growing demand for studies based on complex and massive data from the national health data system (SNDS, formerly SNIIRAM). It indeed seems essential to be able to identify in the most possible way reliable as possible, the risks linked to health products in order to ensure health safety and transparency of data for French women. He would like to know if there are resources allocated to the proper functioning of these studies on the themes "endometriosis and meningioma" and "desire for pregnancy and meningioma", which are essential for doctors, in order to ensure good care for patients. Likewise, he would like to know if, in In the event of a change in instructions, patients and doctors are informed quickly and individually.

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