2024-03-29 15:46:05
Are drugs like Androcur, Lutényl or Lutéran at the heart of a new health scandal? Patients having taken these progestogen medications and suffering from brain tumors after taking Androcur drequest compensation for the damage they have suffered, through legal action aimed at holding the State liable.
Two petitions were filed against the National Medicines Safety Agency, ANSM, at the administrative court of Montreuil in Seine-Saint-Denis, learned the Radio France agency with the lawyer of two Androcur victims, Maître Charles Joseph-Oudin. It evokes more than fifty appeals in preparation, out of nearly 450 files identified.
“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,” he declared on franceinfo this Friday. Her clients “are seeking compensation from the State, which appears to be the main responsible for this immense health disaster”he says.
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Contraception, menopause, PMA, acne…
Androcur, a progesterone derivative, can cause meningiomas (brain tumors) in some patients. Progestins are medications used in contraception, in the treatment of certain gynecological pathologies such as uterine bleeding or endometriosis, or hormone replacement therapy for menopause and during the journeys of assisted reproduction, or even against acne. Lawyer Charles Joseph-Oudin questioned, this Friday on franceinfo, “all synthetic sex hormones, progestins, such as Androcur, Lutéran, Lutényl and their generics”, authorized on the French market from the 70s and 80s.
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Did the State wait too long to warn?
The victims accuse the State in particular of delay in implementing preventive measures, while the dangerousness of Androcur and the risks of meningioma 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 has, in fact, been the subject 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”, he denounces.
Legal experts confirm the link between the drug and tumors
Very strict precautions and a toll-free number from 2018
From 2018, the ANSM published a report on the risk of meningioma linked to taking Androcur, in particular establishing “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 medication. Without prohibiting the use of Androcur and its generics, the ANSM then recommended that doctors “to inform patients of the risk of meningioma”, d’“evaluate the benefit/risk ratio for each patient, taking into account the risk of meningioma”, or 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”.
Androcur prescriptions fell by almost 90% between January 2018 and December 2023, according to the ANSM. At the end of November 2023, fewer than 10,000 patients were treated with Androcur compared to around 90,000 at the end of 2017.
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