The European Medicines Agency (EMA) has begun a review of products containing the anti-androgen cyproterone, which is used in the treatment of hirsutism, alopecia, early puberty, amenorrhea, acne, and prostate cancer. They are also used together with an estrogen in hormone replacement therapy.
There are hundreds of such products on the market in various European countries. They are also marketed in many other developed countries, but none have been marketed in the United States or Japan.
The review will look at the risk of meningioma associated with the use of these products. Meningioma is a rare and usually non-malignant tumor of the membranes covering the brain and spinal cord. Surgical removal can lead to serious sequelae such as memory problems, epilepsy, or loss of taste and smell.
Information on the risk of meningioma is already included in the prescribing information for cyproterone products, the EMA notes, and the risk has been known since 2008.
The new review was requested by France, and prompted by a recent French study that found the risk of meningioma with long-term use of these products is higher than was first thought. This study also showed that even after patients had stopped cyproterone treatment for at least 1 year, their risk of developing these tumors was slightly higher than usual, the EMA notes.
The review is being carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for the evaluation of safety issues for human medicines. PRAC is due to make its recommendations on this issue in November.
Concern Over This Issue in France
Medscape France has been reporting on this issue since 2018. It notes that products containing cyproterone and cyproterone acetate (including Androcur® and related generics) are commonly prescribed in France, often for the treatment of resistant acne but also for endometriosis, seborrhea, or ovarian cysts.
According to the ANSM, the French National Agency for Medicines and Health Products Safety, more than 89,000 women received at least one treatment with Androcur or one of its generics in 2017. Gynecologists were the main prescribers of cyproterone acetate (39% of prescriptions), followed by general practitioners (27%), hospital prescribers (15%), endocrinologists (10%), and surgeons and dermatologists (3%).
Medscape France also reported details of a study conducted by the AM/Hôpital Lariboisière that involved 250,000 women exposed to cyproterone who were followed for 7 years.
The study showed a significant dose-response effect. Preliminary results showed that exposure to high dose cyproterone acetate (more than 3 g over 6 months, then continued) is associated with a sevenfold increased risk of meningioma (managed in neurosurgery) compared with women who were taking a lower dose (less than 3 g over 6 months, then stopped treatment).
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Cite this: Risk of Meningioma With Cyproterone:EMA Review Begins - Medscape - Jul 12, 2019.
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