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Risk of meningioma: the State prosecuted for having informed patients too late

Six years after the publication of the report from the Medicines Agency (ANSM) incriminating Androcur and its generics, a progesterone derivative causing brain tumors (meningiomas), the pain is still acute for the victims.

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Risk of meningioma: the State prosecuted for having informed patients too late

Six years after the publication of the report from the Medicines Agency (ANSM) incriminating Androcur and its generics, a progesterone derivative causing brain tumors (meningiomas), the pain is still acute for the victims. In 2019, an association of victims of medical errors (AAVAC) had already launched a group legal action against Bayer Health Care, the laboratory producing Androcur. While five other progestins are now known to induce the same effects on the brain, patients struggle to obtain relief. According to the newspaper Le Monde, two new appeals were filed before the administrative court of Montreuil this time, on March 7, 2024. The plaintiffs accuse the ANSM of breaching its obligations by having informed users too late about the risks of tumors. brain, despite the existence of evidence.

Also read: The link between progesterone and brain tumor is confirmed

Authorized in particular to treat excessive hair growth (hirsutism) in women, Androcur has been widely prescribed outside of its initial indications, against acne or as a contraceptive. Abusive prescriptions which also concern Lutéran, Lutényl as well as other progestins (Surgestone, Colprone, Depo Provera), now also singled out.

The victim at the origin of the two appeals confided to Le Monde that she had been referred to Androcur by her gynecologist. A treatment that she took for six before discovering more or less accidentally, in 2016, that she was suffering from not one but three brain tumors called meningiomas. Considered benign, these tumors theoretically do not develop into cancer but can leave disabling after-effects on a daily basis (headaches, problems with concentration, balance, vision, epilepsy) and are irreversible, even after their removal. This was the case for this woman who ended up obtaining recognition of the link between her illness and Androcur thanks to a medical expertise carried out in 2022.

Around fifty appeals, based on 450 other patient files, should also follow. “These cases concern women treated with Androcur or Lutéran or Lutényl,” specifies Charles Joseph-Oudin, lawyer in charge of the case. Of the 50 expertises requested, 20 have been completed. All maintain a causal link between taking these treatments and the appearance of meningioma and recognize the responsibility of the State in the delay in information communicated to patients. »

The victims accuse the authorities of having delayed in putting in place concrete prevention measures even though the risk of tumors had been known for a long time. The first clues appeared in 2004 when five cases of meningiomas were reported to health authorities. One thing in common: all the patients had been treated with Androcur. Following this first alert, cases trickled down, as did several scientific publications. But we had to wait until 2018 for prevention measures to be put in place, when the ANSM made public the first official report demonstrating a tumor risk 7 to 20 times higher for women treated with Androcur at high doses for a period of time. long term (one year or more). Another year is necessary for the agency to publish a press release aimed at health professionals and patients to inform them of the risks. From then on, prescribers are asked to no longer deliver the treatment outside of its marketing authorization or in the event of the existence or history of meningioma.

Also read: Androcur: victims want to go to court

According to the ANSM, fewer than 10,000 patients were still on Androcur at the end of November 2023, which represents a 90% drop in prescriptions since 2018. Concerning the rest of the more recently incriminated progestins (Lutéran/Lutényl, Depo Provera, Colprone, Surgestone) , recommendations have also been made to tighten prescriptions to very specific cases, particularly in the context of endometriosis, a pathology for which there are few treatment options.

The other criticism made to the authorities is the maintenance of the “benign” character still associated (wrongly) with meningioma in the medication leaflet. “Given the seriousness of the pathology as well as its after-effects, this practice is inappropriate because it minimizes the consequences for patients. Which is unacceptable,” says Emmanuelle Huet-Mignaton, president of the association of meningiomas victims, AMAVEA. With its support, the victims hope that a compensation system will be quickly put in place, on the same principle as that established for example for the Mediator. “Unfortunately we have been asking the Ministry of Health for more than a year without a response. We will persist until the victims win their case,” underlines Charles Joseph-Oudin.

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