A study conducted by the University of Bristol provides additional evidence that cyproterone acetate (CPA), marketed in France under the name Androcur, is indeed linked to an increased risk of a benign brain tumor called meningioma.
- Containing an active ingredient called cyproterone acetate, Androcur and its generics are prescribed for women suffering from hirsutism, against acne, endometriosis or as a form of contraception. Men with advanced prostate cancer may also be prescribed it.
- In France, the Medicines Agency has set up a toll-free number (0 805 04 01 10) accessible Monday to Friday from 9 a.m. to 7 p.m. “to answer questions from patients on Androcur.
Cyproterone acetate (CPA) is indeed responsible for the increased risk of meningioma, a brain tumor that is generally benign but which can have a strong impact on quality of life, in particular by causing a disability linked to compression of the brain.
This is the conclusion of a new study published in Scientific Reports Friday, February 4. Conducted by researchers at the University of Bristol, England, it confirms the results of other work, including a 2018 Medicare study, and suspected Androcur to increase by up to 20 (after 5 years of treatment), and even more, the probability of meningiomas in women treated for a long time and at high doses.
Meningiomas when the drug is used in high doses
Marketed since the 1980s by Bayer laboratories, Androcur is a progestogen prescribed for years to women suffering from hirsutism, that is to say an extreme development of hair, but also against acne, endometriosis or as contraception. Belonging to the class of steroidal antiandrogens and containing an active ingredient called cyproterone acetate, Androcur is also used in men to treat advanced prostate cancer.
In this new work, and given the widespread use of cyproterone acetate, the researchers performed a meta-analysis from four studies involving a total of 8,132,348 patients. The aim was to assess whether high-dose use of this drug was associated with the incidence of meningiomas.
The sample included 165,988 patients identified as taking cyproterone acetate at varying doses. Using this data, the team analyzed the occurrence of meningiomas in patients using high-dose cyproterone acetate compared to those using low doses. A significant association between the use of high doses and an increased risk of meningioma was indeed found, which was not the case with low doses.
“The cause of meningiomas is controversial but there is strong evidence suggesting a plausible role of sex hormones in causing meningiomas, points out Keng Siang Lee, medical student and lead author of the study. We know he has a predilection for women, especially after puberty.”
A limitation of the conditions of use in France and in Europe
In the light of these results, the researchers point out that the prescription of Androcur at high doses, in particular for off-label indications, must be considered with caution. They also suggest that a “Systematic screening and monitoring of meningiomas by brain MRI” be offered to patients who are prescribed cyproterone acetate in high doses and for long periods of time.
This is the case in France. Since 1er July 2019, any new patient starting treatment with Androcur or one of its generics is systematically informed of the risk of tumor linked to its prolonged use. In early 2020, the European Medicines Agency (EMA) also issued a series of recommendations to limit its use. Now it should only be used in cases of severe hirsutism where other treatments have failed. Its use is maintained in the treatment of prostate cancer. In the event of a history of meningioma, Androcur can no longer be used, even at a low dosage.
For the time being, the researchers acknowledge that they do not know whether “cyproterone acetate below a certain threshold may be completely safe in terms of meningioma risk” and therefore wish to continue clinical research on the link between the drug and the risk of intracranial meningioma.
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