Androcur is a hormonal medication that increases the risk of meningioma, a tumor of the meninges.
The drug Androcur® has caused scandal in recent years because it can increase the risk of meningioma, a tumor developing in the meninges, in the brain. This risk was identified by the manufacturing laboratory Bayer in 2004 and recognized by the French Medicines Agency (ANSM) in 2009. “No information was communicated to prescribing healthcare professionals or patients at that time, exposing thousands of women to serious danger” regrets the victims’ association Amavea on November 5, 2024 in a press release in which it announces filing a complaint against X and requesting the opening of a judicial investigation into the management of risks and side effects of the drug.
What is Androcur?
Androcur® is a hormonal medication marketed by the Bayer laboratory since the 1980s. It contains cyproterone acetate, a derivative of progesterone. It has an antihormonal action, opposing the action of androgenic hormones, mainly testosterone. It also has a contraceptive effect. Androcur is only authorized:
- in case of excessive hair growth (hirsutism)
- in case of prostate cancer
- in case of paraphilia (paraphilias consist of sexual arousal by atypical objects, situations, and/or objectives)
It is also sometimes prescribed outside its marketing authorization (AMM) as a contraceptive, treatment against acne or in gender transition processes.
What are the dangers and risks of meningioma?
Cyproterone acetate, the active substance in Androcur®, has been monitored since 2009 at European level (European Medicines Agency following a report issued by France) because of the risk of the appearance of meningioma during its use. It is a tumor, most often non-cancerous, developing from the membranes which envelop the brain and spinal cord (the meninges). It can result in various symptoms such as frequent headaches, vision, language, memory and hearing problems, nausea, dizziness, convulsions, loss of smell, weakness, paralysis. This risk has been included in the medication leaflet since 2011. A Health Insurance study showed that:
► The risk of meningioma is multiplied by 7 when treatment exceeds 6 months
►The risk of meningioma is multiplied by 20 after 5 years of treatment.
These risks concern Androcur and its generics.
What to do if you take Androcur?
► Your treatment needs to be reassessed at least once a yearwhether you have been taking it for a short time or for several years.
► In addition, periodic monitoring by brain imaging (MRI) is to be carried out according to the following schedule: an MRI at the start of treatment, to be repeated within 5 years, then every 2 years as long as the MRI is normal and the treatment is continued. If your doctor has not yet ordered a brain imaging (MRI) test, ask him or her to order one for you.
► If the MRI reveals the presence of a meningioma, the doctor will ask you to stop your treatment permanently because it is contraindicated in cases of meningioma (and in cases of a history of meningioma). Your doctor will refer you to a neurosurgeon who will assess the treatment to be adopted according to your individual situation.
► Beyond one year of treatment, your doctor must give you each year a certificate of information which you must complete and sign together. To obtain your medication, this annual certificate (or a copy) must be systematically presented to the pharmacy in addition to your prescription.
► Do not stop your treatment without talking to your doctor. The latter is in fact best able to judge your care and the relevance of stopping treatment by taking into account your personal medical situation as a whole (individual benefit/risk).
► If you think you have developed a side effect in connection with your treatment, we invite you to declare it directly on the adverse event reporting portal : https://signalement.social-sante.gouv.fr
What are the side effects of Androcur?
► In women:
- breast tension
- change in libido
- period disorders (light bleeding between periods, stopping of periods, etc.).
► In humans:
- reduction in sperm production, usually reversible when treatment is stopped, which may lead to temporary sterility
- gynecomastia
- impotence
- decreased libido
- sweats
- hot flashes
- anemia
- bone loss with prolonged treatment.
► In women as in men:
- weight change
- shortness of breath
- heavy legs
- migraine
- headache
- rash
- fatigue
- hustle
- depressive state.
► Rarely:
- hepatitis
- thromboembolic accident
- meningioma
What are the contraindications of Androcur?
Androcur® should not be used in the following cases:
- serious liver disease, certain rare diseases causing excess bilirubin in the blood
- tuberculosis or deterioration of general condition linked to a serious illness
- thromboembolic accident (phlebitis, pulmonary embolism, myocardial infarction, etc.) old or occurring during treatment
- severe depression
- sickle cell anemia
- in the event of a history or existence of a meningioma,
- history of herpes gestationis, jaundice or prolonged itching during pregnancy (50 mg tablet).
- for the treatment of acne, moderate hirsutism or in cases of menopause,
- in children and postmenopausal women.
Is Androcur available with or without a prescription? What price?
Androcur® is only available on medical prescription from list Iwhich can only be obtained upon presentation of a prescription written by a doctor, dental surgeon or midwife. Medicines on list I (red box on the box) can only be dispensed for the duration of treatment mentioned on the prescription. The drug is sold at a price of 9.50 euros per box (50 mg tablets) and reimbursed at 30% by Health Insurance.
