2 -page article by Perrine Vennetier
on Androcur and association in Que Choisir Santé magazine in March 2020
At 53, Emmanuelle Mignaton-Huet discovers that several meningiomas (non-cancerous tumors) have developed in her brain. In question: the androcur (cyproterone acetate) which she has taken for over 10 years. After an operation fraught with consequences, she created Amavea an association to support and make the other victims of drugs heard.
" Speaking exhausts me. This is the sequelae that I have of the operation. Two years ago, Emmanuelle Mignaton-Huet undergoes surgery to remove a brain tumor that compressed her brain . She wakes up aphasic, deprived of words. " I had to relearn everything ," she explains. But since she found the use of her voice, Emmanuelle hears the voice of those who, like her, are victims of Androcur (cyproterone acetate). Because it is him the cause of brain tumors (meningiomas) that have developed in his brain.
The Androcur is normally authorized in women only in the event of excess of major hair (hirsutism) and very annoying. But in many cases, as for Emmanuelle, it is given without authorization. For Emmanuelle, the prescription is made for endometriosis, a uterus fabric disorder which often causes disabling pain. " For that, I must say that this medication relieved me" recognizes Emmanuelle. For the rest ...
A long degradation
Started in 2003/2004, this hormonal treatment made him take 30 kilos and lose his libido (" it's a chemical castration, that we do not say it often ") before causing even more serious adverse effects. First, his leg shies from time to time, as " if my brain was disconnected " describes Emmanuelle to whom her doctor only declares: " you are too big, made of sport ". Then violent headaches occur, diagnosed as simple " tension headache ". In addition, there are memory disorders and such a tiredness that Emmanuelle is struggling to continue its activity as a financial analyst, continues the sick leaves and is forced to go into disability. Finally "awkwardness" are multiplying, objects escape him, until this morning in 2017 when Emmanuelle wakes up with an inert right hand.
The cliché of the MRI requested in an emergency immediately reveals "big masses" in the brain: five meningiomas (tumors of the meninges), not cancerous but which cause dysfunctions. " I was almost relieved that we finally find something, a cause to my problems and not only psychological! ». Everything goes very quickly afterwards. You have to operate to withdraw one of these meningiomas, an appointment is made, in October 2017 the tumor is removed. A surveillance program is set up with an MRI every 6 months. Emmanuelle begins his convalescence.
Little conscientious doctors
At the Sainte-Anne Hospital in Paris where Emmanuelle was operated on, the role of the drug in the occurrence of meningiomas is immediately mentioned. " But I didn't really believe it, besides I hadn't even stopped the medication after the operation!" But in January 2018, I understand that I have to stop. At that time, my gynecologist tells me " me it surprises me that there is a link " and " if you stop, you will suffer ", deplores Emmanuelle for whom, retrospectively, things could have happened differently. " In 2014, in Caen, I discussed with a gynecologist asking, " It's been a long time since I take hormones, would there be another solution? " had put me back that we are not changing a treatment that works . however , the risk of meningioma in the event of prolonged use was clearly mentioned in the notice (see Box Chronologie). " But precisely, when you have been taking a medication for a very long time, there is no reason to return to read the notice ," said Emmanuelle.
Anger rises but struggles to express themselves. She is researching, in touch with other people, attending a Facebook group, written to newspapers. In April 2018, she met Nathalie Grillot, also victim of Androcur. From there is born the idea of an association. Emmanuelle Meeting Marine Martin, who fights for the cause of disabled children born under Désakine and Irène Frachon, who launched the alert for the mediator. In January 2019, the statutes were filed for AMAVEA, a Méningiomes association due to cyproterone acetate, aid to victims and taking into account other molecules.
Victim assistance
The object of the association is wide: provide support to victims, inform about drugs, legally support those who want to obtain compensation. "People are very demanding from the judiciary," she analyzes. And it is true that some are terrible financial situations, they need financial compensation. ” Meningioma is indeed a benign tumor but its consequences are not. Some women become epileptics, many people can no longer work.
Emmanuelle Positive: “ The advantage of my own disability is that I have time to help others. Because the compensation is not only obtained in court but in the entry. " On the phone I try to provide support and health information to people, I listen to their anger, their suffering . And I try to spend their speech and send a message to the pharmaceutical laboratories ”. Because for Emmanuelle, laboratories must assume their share when the risks linked to the undesirable effects of the drug. A track? The creation of a common compensation fund.
Victims of the drug: the double penalty
Victims of serious side effects of serious drugs have two ways, which each show obstacles making compensation difficult.
- The so -called amicable path . Organized by regional CCIs (conciliation and compensation committee), it is the shortest, the least expensive and undoubtedly the least trying. In theory, it allows to compensate drug accidents when no one is responsible (therapeutic hazard or lack of luck). However, a cause and effect relationship must be demonstrated between the drug and the damage. However, according to experts and CCIs, great disparities in judgment are noted. Another problem: the necessary severity thresholds are high. For example, it is necessary to justify the loss of an eye to be able to benefit from the procedure. However, many damage, bearing chronic and really disabling, do not reach this level.
-The legal path . This procedure before the courts is longer, expensive and difficult than the amicable way. But the compensation amounts are generally higher there. As with the amicable route, it must be demonstrated that the drug is in question in the occurrence of damage suffered. If the adverse effect is not in the notice, the cause and effect relationship is often difficult to prove. If the adverse effect is in the instructions, it is easier ... But then, the regulations are such, that it actually excludes the laboratory! It remains possible to engage the responsibility of the prescriber, if, for example, he prescribed the drug unjustified.
Androcur> a long -standing known risk of a long -standing tumor
1980: Androcur [Cyproterone acetate, 50 mg] obtains its marketing authorization. This hormonal treatment, from the family of progestins, is authorized for the treatment of severe hirsutism (excess of hair) in women and prostate treatment in men.
2008: The risk of multiple meningomes linked to the taking of cyproterone acetate is presented during a medical congress.
2009: The European Pharmacovigilance Authorities are studying the issue.
2011: The notices and RCP [The official medication sheet] are modified to mention the risk of meningioma. An antecedent or the occurrence of such a tumor becomes a contraindication.
2014: A Survey of the Pharmacovigilance Center in Strasbourg has 44 cases of people who have had a meningiom under progestin.
October 2018: The Medicines Agency (ANSM) publishes the results of a quantification study: The risk of meningioma is multiplied by 20 in the event of taking more than 5 years. At the same time, recommendations for the care of patients are disseminated.
March 2019: A health insurance report confirms " a very wide use out of AMM " (without official authorization) of the Androcur and its generics, with an absence in 85 % of women of research exams of a hirsutism. The main diverted uses are contraceptive and against acne.
1 , 2019: New conditions for prescribing and issuing cyproterone acetate are established: doctors must hand over an information sheet and sign a discount certificate.
-Amaeva: https://amavea.org/ 06 07 58 67 96
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