Press review on " Cyproterone acetate: assessment of the impact of measures to reduce the risk of intracranial meningiomas"
The daily newspaper of the doctor 1/12/2022: Restriction of the Androcur: the authorities welcome a drop in the risk of meningioma
The Androcur (Cyproterone Acetate) is now only used in a small number of cases where it is particularly effective and the measures taken since 2018 have allowed a clear reduction in the risk of meningioma. There was no postponement of patients to other products at risk, welcomed the National Agency for Health Products (ANSM) on December 1
The Pharmacies Monitor 2/12/2022 :
The risk reduction measures of meningioma associated with the use of high doses of cyproterone acetate ( Androcur and generics) implemented since 2018 have paid. This is what stands out from the balance sheet established by the National Agency for the Safety of Medicines (ANSM) and the Scientific Interest Grouping Epi-Phare, reporting on a "deep change in practices between 2018 and 2021".
During this period the number of people treated by cyproterone acetate at a dose greater than or equal to 25 mg dropped by 88 % in women and 69 % in men. Almost 82 % of people treated in 2018 were no longer at the end of 2021. A postponement was noted for 35 % of women to other sex hormones, or to Spironolactone, anti -festering diuretic, for 5 % of women and 3 % of men. Many patients therefore seem to have purely and simply stopped their treatment.
Regarding meningioma screening, almost 70 % of women and 50 % of men treated by the molecule in December 2021 had made a brain MRI , in accordance with the ANSM recommendations. The figures are less good at the initiation of treatment with less than 50 % MRI, an examination however recommended before any treatment of treatment.
In the end, the sharp reduction in consumption of cyproterone acetate made it possible to reduce the number of intracranial meningiomas attributable to this medication. The number of operated women went from 95 in 2017 to only 7 in 2021, a fall of 93 %.
The daily life of the pharmacist 2/12/2022
Androcur: a clear reduction in the risk of meningioma
The measures put in place to limit the risk of meningioma under cyproterone acetate (Androcur and generic) were very effective, with a drop in the number of use of this molecule and the number of meningioma operations associated with its taking, according to a study carried out from data from the SNDS (National Health Data System)
Top health 2/12/2022
In 2018, ANSM and health insurance had taken measures to reduce the risk of meningioma linked to the taking of cyproterone acetate (Androcur). And according to a study, they would have been effective by resulting in a sharp decrease in the use of Androcur in exposed persons as well as a decrease in ablations.
A risk of meningioma (almost always benign tumor developed from 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 linked to taking Androcur in women. Even in the short term, after more than six months of high dose treatment (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 its use;
- A recommendation of meningioma screening by brain imaging before and during treatment;
- The implementation of an “annual information certificate”, only issued by the prescribing doctor, co-signed with the patient and essential for any provision of the product in pharmacies;
- Regular information of health professionals and patients.
For what pathologies and with whom is the Androcur prescribed? Cyproterone acetate is indicated in women in the treatment of certain hormonal diseases such as an increase in the hair system or in case of endometriosis . In men, the drug may be prescribed in the treatment of certain forms of prostate cancer and also makes it possible to reduce male hormones (testosterone, etc.) 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 that it no longer prescribe an Androcur to deal with acne, seborrhea or moderate hair problems.
Have 2018 measures been effective?
The study conducted by the EPI-Phare interest group over the period 2010-2021 revealed a profound change of practices between 2018 and 2021.
- A decrease in the number of people treated by cyproterone acetate
At the end of 2021, the number of people treated in high doses decreased considerably compared to August 2018 with a drop of 88% in women, by 69% in humans and 50% in transgender women.
In December 2021, 7,900 people used high -dose cyproterone acetate against 55,000 in August 2018 and 85,000 in January 2010. Researchers also noted a 94% decrease in treatment initiations by doctors.
- A decrease in the number of surgical ablations of meningiomas
It is established that the size of meningiomas associated with cyproterone acetate decreases or stabilizes when stopped decreases or stabilizes when you stop treatment: their systematic removal is therefore not recommended, the surgical intervention that can be heavy and painful for the patient.
The study also reveals a very marked decrease in the number of meningioma operations associated with cyproterone acetate: only 7 women were operated in 2021 against 95 in 2017. This drop is also observed while MRI screening has significantly progressed: more than half of the persons treated were dedicated in 2021 against barely 10% in 2018. “ Men under cyproterone acetate had thus made a brain MRI screening, in accordance with the recommendations of the ANSM , “concludes the drug agency.
The ANSM and health insurance nevertheless continue to monitor and believe that the impact study should be continued, " just like those devoted to nomestrol and chlormadinone acetate, which are in progress" .
Egora 2/12/2022
The measures taken since 2018 to limit the risk of meningioma associated with the use of cyproterone acetate (Androcur and its generics) in high doses, seem to bear fruit. Thus, according to the scientific interest group (GIS) Epi-Phare, which conducted a study from data from the National Health Data System (SNDS) over the period 2010-2021, there were fewer prescriptions for this processing, but also more follow-up and less surgery for meningioma.
