Androcur has been widely prescribed to women for endometriosis, acne or as a means of contraception, but it can cause brain tumors in some patients.
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Two administrative requests were filed against the National Medicines Safety Agency (ANSM) before the administrative court of Montreuil, in Seine-Saint-Denis, franceinfo learned from the lawyer of two Androcur victims, Charles Joseph -Oudin, confirming information from World.
These requests aim to obtain compensation from the State for victims of this drug, Androcur, a progesterone derivative, which can cause meningiomas, brain tumors, in certain patients. This drug, initially developed against hirsutism, and marketed by Bayer since the 1980s, has been massively prescribed to women against endometriosis, acne or as a means of contraception. In addition to Androcur, the lawyer calls into question “all synthetic sex hormones, progestins, such as Androcur, Lutéran, Lutényl and their generics”.
The risks of Androcur known since the 2010s
The victims accuse the State in particular of delay in implementing preventive measures, even though the dangerousness of Androcur and the risks of meningiomas have been known for several years. On an ANSM publication dating from 2022, we can read that “this risk has been known since the 2010s”. In 2009, Androcur was, in fact, the subject of special monitoring at European level for the risk of the appearance of meningioma. In 2011, the European Medicines Agency requested that this risk be included in the package leaflet. For Charles Joseph-Oudin, these side effects have been known for even longer, “since 2004, there have been clues and suspicions” and this therefore constitutes “a fault of the health authorities who wait until the risk is certain to inform patients, whereas it is necessary to inform them when a suspicion of risks exists”.
From 2018, the ANSM published a report on the risk of meningioma linked to taking Androcur. In particular, she established “an increase in the risk of meningioma with the duration of use”. The ANSM had also set up a toll-free number for patients exposed to this drug. Without prohibiting the use of Androcur and its generics, the ANSM then recommended that doctors “to inform patients of the risk of meningioma”of“evaluate the benefit/risk ratio for each patient, taking into account the risk of meningioma”or even to prescribe it only “in compliance with the indications in the marketing authorization and at the lowest possible doses, and over a short period of time”.
450 victims identified
Two requests have therefore been filed at present, but lawyer Charles Joseph-Oudin mentions more than fifty appeals in preparation, out of nearly 450 identified files. “Given the number of victims and the responsibility of the State, we would like to see the establishment of a compensation system for these women, based on the model of what was put in place for Médiator or Dépakine”, declares the lawyer. He summarizes the action of his clients as follows: “They are seeking compensation from the State, which appears to be the main responsible for this immense health disaster.”