Cyproterone acetate, which is marketed under the name Androcur (Bayer), has seen a sharp decline in prescriptions since 2018. This progesterone derivative suppresses the effects of male sex hormones. The ANSM on Thursday 1 welcomed actions taken by Medicare and the National Agency for the Safety of Medicines (ANSM) since 2018 that have reduced the risk of meningioma associated with the use of this progestogen.Verse December, citing the study by the Epi-Phare Scientific Interest Group, conducted from the National Health Data System and covering the period 2010-2021. This molecule, which has been on the market since the 1980s, was originally prescribed to combat hirsutism, and later was used as a contraceptive and in the context of gender transition.
The risk of meningioma, a predominantly benign brain tumor, increases seven-fold for women treated with high doses of cyproterone acetate over a long period (more than six months) and twenty-fold after five years of treatment with a daily 50 mg tablet, a study highlighted . From Medicare published in British Medical Journal. “The higher the dose, the greater the risk, with particularly high risks in the anterior part of the base of the skull.”Alan Weil, Vice President of Epi-Phare.
88% reduction in the number of women treated
It was Sebastien Froelich, a neurosurgeon in Strasbourg – and today in Lareboisiere (Paris) – who first sounded the warning in 2007, after caring for several patients on whom he had to operate for several meningiomas. . After its study, ANSM warned the European Medicines Agency in 2009 of this risk, and added it to the instructions for Androcur and its medicines. This increased risk was then identified in new drug studies, which led to health agencies informing healthcare professionals and patients of indications aimed at limiting the use of these molecules and encouraging screening of meningiomas with MRI of the brain.
A decrease in the number of surgical removal of meningiomas was also observed
As a result, the number of people treated with high doses of cyproterone acetate decreased dramatically at the end of 2021, to 7,900 people, from 55,000 in August 2018 and 85,000 in January 2010, with a sharper drop for women (-88%) than for men (-69%). ) or transgender women (-50%), according to an Epi-Phare study. This study is the first to show the profound change in practices since 2018.said Christelle Ratignier Carbonel, Director General of ANSM.
Also at risk is nomegestrol acetate (Lutenyl and related drugs) and chlormadinone acetate (Loteran and related drugs), two other progestogens, taken by 450,000 women annually. All progestogens are monitored.the agency said.
A decrease in the number of surgical removals of meningioma was also noted: 7 women underwent operations for meningioma associated with cyproterone acetate in 2021, compared to 95 in 2017, reports the ANSM. “The size of cyproterone acetate-associated meningiomas decreases or stabilizes when treatment is discontinued, and their systemic removal with a large and risky surgical intervention is not recommended,” said Isabelle Yoldjian, from ANSM.
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