After numerous recommendations with regard to Androcur and the link with meningioma, the ANSM is gradually setting up new measures for the information of patients treated with Androcur (Cyproterone Acetate) and the risk of meningioma.
Information letters for patients
New measures were taken in June by the ANSM following the establishment of the link between the capture of Androcur and the development of Méningioma , intracranial tumors.
Information letters co-signed by health insurance and ANSM are currently addressed to patients and health professionals.
Androcur
prescriptions in the last 24 months or its generics will receive this information letter on the risks of meningioma under processing of Androcur .
Doctors who have prescribed this medication in the last 24 months will also receive this news letter.
The goal is that patients and doctors meet to discuss this risk and the follow -up to their treatment.
The risks of meningioma, which can lead to a heavy and risky neurosurgery operation are now known. Even 1 cm meningioma can be a problem depending on the location.
This mail recalls that prolonged and high dose uses as well as out -of -AM indications such as acne , seborrhea and moderate hirs are to be avoided and that the use of androcur (cyproterone acetate) in children and menopausal women is not recommended.
Patients who have been treated in the past and who are no longer so (and therefore who will not receive mail) can consult a doctor so that he performs a clinical examination and judges the opportunity to prescribe a brain MRI in order to detect a possible meningioma.
Patient / doctor certificate
In addition, the ANSM sets up an information certificate on the risks of meningiomas, side effects of taking the Androcur or its generics. It must be signed each year by the patient and his prescribing doctor and be given to the pharmacist for any issuance of these drugs.
Thus, from July 1, 2019, for any patient who begins a treatment, or before January 1, 2020, for any patient under treatment, (in order to give him time to review his doctor), the doctor must:
• inform the patient of the risk of meningioma and give him the information sheet as well as a copy of the annual information certificate that they will have filled and signed together during the consultation,
• Evaluate Well-to be prescribed by taking into account the individual benefit/risk ratio, then again each year,
• for patients who start a treatment of Androcur brain MRI systematically carried out ; For patients under treatment consider control by MRI if the pursuit of treatment is decided,
• as long as the treatment is maintained, prescribe an MRI no later than 5 years after the first MRI and then every 2 years if the previous MRI is normal.
You will find all this information on the ANSM website: Cyproterone acetate in the form of tablets dosed at 50 or 100 mg (Androcur and its generics): measures to strengthen information on the risk of meningioma - Information point
Participation of Amavea in the development of these documents
The implementation of these documents was initialized in the fall of 2018. Nathalie Grillot, secretary of the AMAVEA association , actively participated in the revision of documents from the first meetings. Then, this work continued and following its creation in January 2019, we were able to continue this work within the framework of the association.
These documents are very important to inform patients about the risks of developing meningiomas following the taking of Androcur or its generics and the association is there for the support of any person with questions, concerns, on the subject.
We also want to reassure: taking Androcur greatly increases the risk of meningioma but all people under this treatment do not necessarily develop the tumor. However, some neurological symptoms are significant. You will find this information in the association's flyer and you can contact us for any further information .
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