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18181

Question 18181 — pharmacy and medicines

answeredFrance· National Assembly· FR

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3 February 2019

Summary

Ms. Florence Provendier draws the attention of the Minister of Solidarity and Health to the effects caused by the drug androcur, the commercial name of cyproterone acetate, as well as its generics. Marketed since the 1980s, androcur makes it possible, in particular, to attenuate the activity of male hormones, indicated in women for the treatment of hormonal diseases. This medication is prescribed to nearly 80,000 women in France. He can also be prescribed to treat endometriosis or acne, even though these cases do not correspond to its marketing authorization (AMM). In a study published in August 2018, the ANSM and health insurance highlighted the adverse effects of the drug, increasing, in particular, the risk of benign brain tumors. This risk of benign tumor for patients treated with high doses would be multiplied by 20 for those who have been taking treatment for at least 5 years, and 7 for those treated for more than 6 months. In addition, according to the ANSM survey, 500 women had to undergo one or more surgical interventions after developing large meningiomas. Following this publication, the ANSM announced the establishment of a toll-free number to answer questions from patients treated with androcur. Many victims request the creation of a “special androcur fund” on the same model as the funds created for victims of depakine or the pick. Faced with this observation, she asks him to please specify the measures taken by his ministry in favor of victims of androcur.

Machine translation from French. The official text remains authoritative.

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