Victims of endometriosis drug file new lawsuit against X

HEALTH – One ” bankruptcy “ actors in charge of Androcur security. This is what Amavea denounces, an association of victims of this progestin drug causing brain tumors, which filed a complaint against X on Tuesday, November 5.

Revealed by The Worldthis new judicial stage of “ the Androcur affair » covers the offenses of administration of a harmful substance, involuntary harm to the integrity of the person, endangering others, failure to report an adverse effect and aggravated deception.

A medication prescribed for endometriosis

Androcur, a pill created to combat hirsutism (a disorder of hair growth), has been prescribed by doctors for years to combat endometriosis or acne, but also as a means of contraception. However, as early as 2007, health professionals were warning about the risk of meningioma, a tumor of the membranes surrounding the brain, linked to the drug marketed by Bayer. In 2018, epidemiological studies established that at high doses, the risk increases by 7 after six months of treatment, and by 20 after five years of taking the drug.

For the lawyer of the Amavea association and its president, interviewed by AFP, “this excess risk, identified by the laboratory in 2004, was then recognized by the firm and the ANSM (medication safety agency, editor's note) in 2008/2009. However, no information was communicated to prescribing health professionals or patients before 2019”. It was only in 2011 that the risk of tumor was mentioned for the first time in the Androcur package leaflet by the European Medicines Agency.

Determine negligence and establish the responsibility of the actors

“It is now obvious that those responsible for the safety of Androcur – Health Agency, laboratories, doctors – failed in the management of the side effects of this drug”write Master Charles Joseph-Oudin and Emmanuelle Mignaton, the president of Amavea, in a press release accompanying this complaint.

“Amavea, representative of thousands of victims, wants an investigation to be carried out to determine the negligence committed and establish the responsibility of the actors involved”they continue, asking for the appointment of an investigating judge. According to the complaint, “starting in 1998, cases of meningiomas were regularly reported to laboratories marketing Androcur”.

This year only, “the Health Authority and the Laboratory are implementing a risk management plan which included, among other things, the dissemination of targeted information to patients taking Androcur”they criticized.

This is not the first legal action in this case. The National Medicines Safety Agency (ANSM) is the subject of requests before the administrative court of Montreuil, in Seine-Saint-Denis. Requested by The Worldthe ANSM did not wish to comment.

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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