CASE. Androcur scandal: how a “miracle” drug caused tumors in thousands of patients

CASE. Androcur scandal: how a “miracle” drug caused tumors in thousands of patients
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Introduced in 1980, this treatment for acne, hair loss or hirsutism, sometimes even as a contraceptive, has caused the appearance of meningiomas in patients. A victims’ association is now demanding accountability from the State.

Marketed by the German laboratory Bayer in 1980, Androcur has enjoyed dazzling success since its creation. Acne, hair loss, hirsutism, irregular periods… The pill remedies hormonal disorders thanks to cyproterone acetate, a derivative of progesterone which inhibits the effects of male sex hormones. On paper, this remedy looks like a miracle. However, since 2004, voices have been raised in the medical profession to denounce its link with the risk of developing meningiomas, tumors of the meninges, benign in 90% of cases, but which can be aggressive or even malignant. Twenty later, an association helping victims of Androcur (AMAVEA) attacked the State for not having communicated to patients the necessary information on the risks of the drug.

Risks multiplied by 7

It was in 2007 that neurosurgeon Sébastien Froelich was the first to openly raise the alarm. It will be necessary to wait until 2011 for the risk of tumor to be mentioned in the Androcur instructions by the European Medicines Agency. Furthermore, the prescription of Androcur is now limited to cases of severe hirsutism and prostate cancer.

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Progress deemed insufficient by Dr. Froelich, who is calling for investigations. Two will be launched in 2018 and 2019 under the aegis of the Agency for the Safety of Medicines and Health Products. The results suggest that the risk of meningioma is multiplied by 7 for women treated with high doses over a long period (more than 6 months) and by 20 after 5 years of treatment.

Furthermore, they confirm the role of Androcur in the occurrence of meningiomas in 500 patients over nearly a decade (2007-2015) and recognize that two other progestogen drugs potentially have the same side effects: Lutéran and Lutényl. Figures that are far below reality according to Emmanuelle Huet-Mignaton, president of the Androcur victims’ assistance association (AMAVEA): “Between 2007 and 2023, 4,000 women were operated on for meningioma caused by progestin.

The victims’ way of the cross

On March 7, 2024, the Androcur affair resurfaced in the public debate. AMAVEA has just filed two requests with the court against the State. “The fault that we attribute to the State, according to their lawyer Master Oudin, is the following: not having correctly disseminated information relating to the health risk posed by taking Androcur to doctors and patients. Consequence: the latter respectively continued to prescribe and consume the molecule.”

Currently, 20 files have been assessed by the court and 450 others are being compiled. Victims will have to steel themselves with courage, because the wheels of justice take a long time to get into motion. “These treatment procedures are difficult to implement for the judicial institution,” warns Maître Oudin. “And of course, they are very costly for the victims.” For this reason, the creation of a specific compensation system for victims was requested by the association, which engages the financial responsibility of the State.

Although the legal procedure constitutes a way of the cross for the victims, they find comfort in the fact that Androcur finds itself placed at the center of public debate. “It is thanks to the media that most women suffering from meningioma discover the potential link with taking Androcur,” emphasizes Maître Oudin. In addition to the public, doctors must become aware of the risks inherent in this medication. We must minimize the ‘exposure to risk!’

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