Less prescribed, progestins remain under surveillance

Cyproterone acetate, marketed under the name of Androcur (Bayer), has seen its prescriptions strongly decrease since 2018. This progesterone derivative inhibits the effects of male sex hormones. The measures taken by health insurance and the National Medicines Safety Agency (ANSM) since 2018 have reduced the risk of meningioma linked to the use of this progestogen welcomed the ANSM , Thursday, December 1 ^, citing the study of the EPI-Phare scientific interest group , conducted from the national health data system relating to the period 2010-2021. The molecule, marketed since the 1980s, was originally prescribed to combat hirsutism and then was used as a contraceptive and in the context of gender transition.

The risk of meningioma, a most often benign brain tumor, is multiplied by seven for women treated with high doses of cyproterone acetate over a long period (more than six months) and by twenty after five years of treatment with a 50 mg tablet per day, had highlighted a study of health insurance published in the British Medical Journal . "The higher the dose, the greater the risk with a particularly strong risk in the anterior part of the skull base ," pointed Alain Weill, deputy director of Epi-Phare.

88 % drop in women treated

It was Sébastien Froelich, then neurosurgeon in Strasbourg - and today in Lariboisière (Paris) -, who first launched the alert in 2007, after taking care of several patients that he had to operate many meningiomas, and who took Androcur. Following the study he had conducted, the ANSM warned the European Medicines Agency in 2009 on this risk, and had it added to the Androcur notices and its generics. This increased risk was then quantified during new pharmacological studies, leading to health agencies to inform health professionals and patients, indications aimed at limiting the use of these molecules and encouraging meningiomas by brain MRI.

A decrease in the number of meningiomous surgical ablations has also been found

Consequently, the number of people treated by high-dose cyproterone acetate decreased considerably at the end of 2021, going 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 study of Epi-Phare. "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 nomestrol acetate (Lotényl and its generics) and chlormadinone acetate (luteran and generics), two other progestin treatments, taken by 450,000 women per year. "All progestins are under surveillance ," said the agency.

A decrease in the number of meningiomous surgical ablations was also noted: 7 women underwent meningioma operations associated with cyproterone acetate in 2021, against 95 in 2017, indicates the ANSM. "The size of meningiomas associated with cyproterone acetate decreases or stabilizes when you stop treatment, their systematic removal by heavy and risk surgery is not to be favored," said Isabelle Yoldjian, of the ANSM.

Note from the association: These meningiomas do not always decrease when you stop treatment !!!