Less prescribed, progestins remain under surveillance

Cyproterone acetate, marketed under the name Androcur (Bayer), has seen its prescriptions drop sharply since 2018. This derivative of progesterone inhibits the effects of male sex hormones. The measures taken by Medicare and the National Medicines Safety Agency (ANSM) since 2018 have reduced the risk of meningioma linked to the use of this progestogen, the ANSM welcomed on Thursday 1er December, citing the study by the Scientific Interest Group (GIS) Epi-Phare, conducted from the National Health Data System (SNDS) covering the period 2010-2021. The molecule, marketed since the 1980s, was originally prescribed to fight against hirsutism and was then used as a contraceptive and in the context of gender transition.

The risk of meningioma, a mostly benign brain tumor, increases sevenfold for women treated with high doses of cyproterone acetate over a long period (over six months) and twentyfold after five years of treatment with a 50 mg tablet per day, had highlighted a study of Medicare published in the British Medical Journal. “The higher the dose, the greater the risk, with a particularly high risk in the anterior part of the base of the skull”pointed out Alain Weill, deputy director of GIS Epi-Phare.

88% reduction in women treated

It was Sébastien Froelich, then a neurosurgeon in Strasbourg – and today in Lariboisière (Paris) – who first sounded the alert in 2007, after taking care of several patients whom he had had to operate on for numerous meningiomas. , and who were taking Androcur. Following the study he had conducted, the ANSM had warned the European Medicines Agency in 2009 about this risk, and had it added to the instructions for Androcur and its generics. This increased risk was then quantified in new pharmacological studies, leading health agencies to inform healthcare professionals and patients of the indications aimed at limiting the use of these molecules and encouraging screening for meningiomas by brain MRI.

A decrease in the number of surgical removals of meningiomas has also been observed

As a result, the number of people treated with high-dose cyproterone acetate decreased significantly at the end of 2021, to 7,900 people, compared to 55,000 in August 2018 and 85,000 in January 2010, with a more marked drop for women (- 88%) than for men (-69%) or transgender women (-50%), according to the GIS study. “This study is the first to demonstrate the profound change in practices since 2018”said Christelle Ratignier-Carbonneil, director general of the ANSM.

The risk also exists for nomegestrol acetate (Lutenyl and its generics) and chlormadinone acetate (Lutéran and generics), two other progestogen treatments, taken by 450,000 women per year. “All progestogens are under surveillance”the agency said.

A decrease in the number of surgical removals of meningioma has also been noted: 7 women underwent meningioma operations associated with cyproterone acetate in 2021, compared to 95 in 2017, indicates the ANSM. “The size of meningiomas associated with cyproterone acetate decreases or stabilizes when treatment is stopped, their systematic removal by a major and risky surgical intervention is not to be preferred”, said Isabelle Yoldjian, of the ANSM.

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