Androcur: a significant reduction in the risk of meningioma thanks to the measures taken in 2018

A risk of meningioma (almost always benign tumor developed from the meninges) multiplied by 20 after five years of treatment with cyproterone acetate (Androcur). In August 2018, for the first time, a Health Insurance study quantified the risks associated with taking Androcur in women. Even in the shorter term, after more than six months of treatment at a high dose (greater than or equal to 25mg), the risk of meningioma was multiplied by 7.

Alarming figures that had prompted health authorities to take measures to reduce the use of treatment and thus the risk of meningioma, in particular:

A reminder of the authorized indications in order to limit their use;
A recommendation for meningioma screening by brain imaging before and during treatment;
The establishment of an “annual information certificate”, only issued by the prescribing doctor, co-signed with the patient and essential for any delivery of the product in pharmacies;
Regular information for healthcare professionals and patients.

For which pathologies and for whom is Androcur prescribed? Cyproterone acetate is indicated in women for the treatment of certain hormonal diseases such as an increase in the hair system or in the event of endometriosis. In men, the drug can be prescribed in the treatment of certain forms of prostate cancer and also helps to decrease male hormones (testosterone…) in transgender people.

In 2018, the ANSM had maintained the marketing of the drug despite the alert, recalling the absence of an alternative for women suffering from hirsutism, a pathology could have an unprecedented impact on their psychoaffective and social life. However, it recommended no longer prescribing Androcur to treat problems of acne, seborrhoea or moderate hairiness.

Were the 2018 measures effective?

The study conducted by the Epi-Phare interest group over the period 2010-2021 revealed a profound change in practices between 2018 and 2021.

A decrease in the number of people treated with cyproterone acetate

At the end of 2021, the number of people treated with a high dose decreased considerably compared to August 2018 with a drop of 88% in women, 69% in men and 50% in transgender women.

In December 2021, 7,900 people used high-dose cyproterone acetate compared to 55,000 in August 2018 and 85,000 in January 2010. The researchers also noted a 94% decrease in treatment initiations by physicians.

A decrease in the number of surgical removals of meningiomas

It has been established that the size of meningiomas associated with cyproterone acetate decreases or stabilizes on discontinuation decreases or stabilizes on discontinuation of treatment: their systematic ablation is therefore not recommended, surgical intervention may be heavy and painful for the patient.

#Androcur and its generics: the measures taken since 2019 have enabled a significant reduction in the risk of #meningioma

↘️ of the use of Androcur

↗️ imaging tracking

↘️ surgical removal of meningiomas

Study @EPIPHARE: https://t.co/ZH1rKgfbD3 @Assur_Maladie pic.twitter.com/9ldgRneldx

—ANSM (@ansm) December 1, 2022

The study also reveals a very marked drop in the number of meningioma operations associated with cyproterone acetate: only 7 women were operated on in 2021 compared to 95 in 2017. This drop is also observed while MRI screening has significantly progressed: more than half of the people treated were screened in 2021 compared to barely 10% in 2018. “In December 2021, respectively 70% of women and 50% of men on cyproterone acetate had thus undergone meningioma screening by brain MRI, in accordance with ANSM recommendations.“, concludes the drug agency.

The ANSM and the Health Insurance are nevertheless continuing their monitoring and believe that the impact study should be continued, “just like those dedicated to nomegestrol and chlormadinone acetate, which are in progress”.

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