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As of July 1st, any patient starting a treatment with Androcur or its generics must be informed of the risk of tumor related to these drugs and benefit from a brain imaging test, according to the Agence du médicament. "This information concerns mainly women, cyproterone acetate, the active ingredient of these drugs, being in the minority prescribed for men, especially for prostate cancer and badual deviancy (chemical castration for pedophilia and / or repeated rapes)", explains Dr. Jean-Michel Race, Endocrinologist, ANSM.
An information sheet on the risk of meningioma (most often benign tumor) of these drugs will now have to be given by the prescribing doctors to their patients. They will only be able to obtain these medicines in pharmacies on the mandatory presentation of an annual information certificate they have signed as well as the prescribing doctor, as of July 1 for new treatments and January 1, 2020 for renewals. .
The probability of intracranial tumors multiplied up to 20
Androcur (Bayer laboratory) and its generics prescribed to combat severe excessive hair growth (hirsutism) or, outside of its official indication, for endometriosis or acne, can multiply up to 20 (after 5 years of treatment) , and even more, the probability of intracranial tumors in women treated long and high doses.
The study of this risk, made public at the end of August 2018, was carried out by the ANSM and the Health Insurance. The risk was known but quantified for the first time, according to the ANSM. In terms of cumulative doses, it becomes higher over time and can be multiplied by 30 after many years. The number of meningiomas operated or treated by radiotherapy due to prolonged exposure to Androcur in high doses reaches 500 at least, note Alain Weill and Joel Coste of the Health Insurance (Cnam) in a synthesis of the study dated March. This estimate excludes tumors monitored medically. On June 18, the results of a pharmacovigilance survey will be presented and discussed with patient representatives. It concerns meningiomas under Androcur declared between August and the end of October 2018.
The validity of the prescription must be re-evaluated each year
The validity of the prescription must be re-evaluated each year. Brain MRI should be systematic for those starting treatment and considered for treated patients if treatment is continued. As long as the treatment is maintained, the following MRI is performed no later than 5 years after the first, then every two years if the previous MRI is normal.
Between 2006 and 2014, more than 400,000 women were treated with cyproterone acetate. A number that confirms "very wide off-label use", according to the Health Insurance. His prescription "off-label" (outside official indications) as contraception or against acne is not justified, says Dr. Isabelle Yoldjian head of pole drugs in endocrinology-ANSM. But for endometriosis severe and resistant to usual treatments, this molecule can sometimes be justified. A toll-free number 0.805.04.01.10 is available free of charge from Monday to Friday from 9 am to 7 pm to answer questions from patients and their families, says the ANSM.
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