Cyproterone acetote, the active ingredient of the drug, increases the risk of meningioma. France took restrictive measures in 2018.
Androcur worries. This anti-androgen drug is associated with a higher risk of meningioma. On February 14, 2020, the European Medicines Agency (EMA) issued a set of recommendations to limit its use. In France, health professionals were warned in the summer of 2019.
A drug used for 40 years
Androcur contains cyproterone acetate: it helps block androgens, sex hormones. Since the 1980s, the drug has been prescribed to treat hormonal disorders in men and women, such as hirsutism, endometriosis, severe acne or even in the case of advanced prostate cancer. Androcur is sometimes used to do chemical castrations or for transitioning transgender people.
A risk of meningioma multiplied by 20
Several studies reveal a serious side effect of the drug: the increased risk of tumors of the meninges, the membrane surrounding the brain and the spinal cord. This concerned between 1 and 10 patients in 10,000. According to health insurance research, the risk of meningioma is multiplied by 7 for women treated for more than six months and by 20 after 5 years of treatment. Cases have also arisen several years after discontinuation.
From 2018, the National Medicines Safety Agency in France has issued recommendations for healthcare professionals to reduce the risk of meningioma. She finds that between May 2018 and May 2019, the number of sales of Androcur and generics fell by 50% thanks to the awareness of doctors. Since 1er July 2019, patients must systematically sign an information certificate to start treatment with cyproterone acetate. Each patient must also have an MRI when they start taking the drug, and then every 5 years.
A limitation of the terms of use
The recommendations issued by the EMA intensify vigilance around the drug and its generics. Now it should only be used in cases of severe hirsutism where other treatments have failed. Its use is maintained in the treatment of prostate cancer.
If the patient has a history of meningioma, Androcur can no longer be used even in low dosages. Previously, its use in the treatment of acne, seborrhea and mild hirsutism was discouraged as well as for postmenopausal women and children. Prolonged and high-dose use is also to be avoided according to the ANSM. These new recommendations will be sent to healthcare professionals after March.
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