A new health scandal in France? Lotényl, Lotéran ... The risk of a tumor that worries women
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Studies have shown that progestin treatments increase the risk of brain tumors.
the risks of meningioma have been recognized for twelve years in the case of Androcur, a progestogy which has an antihormonal action. For the past year, they have also been documented for Lotényl and Lutéran, two progestins widely used by women with gynecological problems. After the mediator and Dépakine, a new scandal in perspective?
Patricia, 47, 12 years old from Lutényl, operation with aphasia, paresies, 8 months of rehabilitation after a tumor of the non -cancerous brain but which has "rotten her life". Laëtytia, 39, 8 years old of Lotéran, who became a hemiplegic following a meningioma…
There is no shortage of testimonies on the AMAVEA site (1). Women, often, who believed that they had found the solution to their gynecological problems with a miracle molecule, nomestrol acetate for some, of chlormadinone for others. Two progestins that we learned in 2020 that they were as at risk, in terms of prevalence, as Cyproterone Acetate (Androcur) which had made it possible to draw the alarm signal in 2009 and to include the risk of meningioma in the medication notice in 2011.
But it was not until a vast epidemiological study, nine years later, to finally quantify the risk for its cousins, Lotényl and Luteran: a woman who takes one of these treatments for more than six months has approximately 3.3 times more risk of developing meningiom compared to the basic risk, which can even be multiplied by 12 depending on the duration of the treatment, the dose used and the age of the patient.
A shock for the victims, but not necessarily within the National Agency for the Safety of Medicines and Health Products (ANSM) forced to put things in perspective from the risk of the risk. A case of meningioma for 1,000 patients under treatment is also 999 women relieved by a treatment to which they have often been used for several years.
Finally, the ANSM makes a first arbitration in mid 2021
It recommends that it does not use chlormadinone and appointment when the risk benefit ratio is unfavorable (symptoms linked to menopause, irregularities in the menstrual cycle, moderate breast pain and contraceptive uses in women without cardiovascular risk factor).
Read also: Lotényl, Lotéran: "It is often enough to stop treatment for meningioma decreasing"
In cases of favorable risk profit (severe mastopathy, functional hemorrhage, endometriosis), it recommends practicing an MRI when the treatment is continued beyond one year, taking into account the individual benefit/risk ratio. In addition, the doctor must give the patient the information document and a copy of the costed information certificate. Certificate which must be presented in pharmacy to obtain the drug.
Better informed patients
In other words ladies, now you know what to stick to! It's up to you to make your choice in conscience! A way to pass the hot potato to patients, in terms of risk taking, and to make the doctors who are?
Health professionals defend themselves. First, because, even if the risk is increased, it is nonetheless limited. A case of meningioma for 1,000 patients under treatment, remember. This is why AMAVEA does not require the prohibition of these two molecules.
To read also: "Let women take these treatments are well informed of the risk"
Then, because better informed patients, they are better careful patients, including those who were unlucky to the disturbing lottery of the progestins.
"Generally, a meningioma does not change life expectancy," says Professor Franck-Emmanuel Roux, head of the neuroscience pole at the Toulouse University Hospital. But it can alter its quality, at least temporarily. Also, it was towards a lawyer that some victims have chosen to turn for a year. After the mediator and Dépakine, a new health scandal in perspective?
Expertise: deliberated on December 15
Mediator, Dépakine, two scandals that have hit the headlines in recent years. And each time, Charles Joseph-Oudin was there, on the side of the victims.
On April 3, 2019, his cabinet Dante opened a new front against pharmaceutical laboratories by launching legal proceedings on behalf of the victims of Androcur, a progestin based on cyproterone acetate.
To its 150 initial customers, others were added when two additional progestins were pointed out, Nomestrol acetate (Lotényl and its generics) and chlormadinone acetate (Lutéran and its generics).
"There are no elements that require criminal procedure," explains the lawyer. But the civil compensation procedure is launched. There has been a lack of information from patients, while laboratories and health authorities have known risks since the mid -90s in our opinion. »»
On October 29, 2019, Me Joseph-Oudin had obtained a first victory in court when the Bobigny court had ordered legal expertise: 35 are today underway.
Next step on December 15, 2021, in two days, with the deliberation which follows a request for general pharmacological expertise.
Objective: to establish the causal links between taking these progestins and the meningiomas from which the victims suffer. And it doesn't matter if only 1 in 1,000 patient has developed a benign brain tumor taking one of these three molecules. "The risk benefit report is very low and did not deserve to get there," for Me Joseph-Oudin.
“Let women take these treatments are well informed of the risk”
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Emmanuelle Huet-Mignaton co-created the AMAVEA association in 2018.
The Méningiomes Association due to cyproterone acetate, aid to victims and taking into account other molecules (AMAVEA) participates in the “Méningiomes and Progestifififies” working group in the National Medicines Safety Agency (ANSM). Its president returns to the objectives of the association and the advances on the subject.
Created in 2018 following a pharmaco-epidemiology study carried out by the National Medicines Safety Agency (ANSM) on the risk of meningiom during prolonged use of cyproterone acetate (Androcur and its generics), the AMAVEA association is strong today by around 500 members.
It also welcomes people affected by nomestrol acetate (Lotényl and its generics) and chlormadinone acetate (Luteran and its generics), molecules for which an epidemiological study published in 2020 by the ANSM also pointed out an increase in the risk of meningioma.
Its president, Emmanuelle Huet-Mignaton represents the association within a working group “Méningiomes et Progestififies” at the ANSM and bringing together, among other things, neurosurgeons, gynecologists and patient associations. Group that "works on how to inform patients and doctors of the risk of meningioma with progestins and reflects on the future of the use of these molecules," she specifies.
She explains the objectives of her association and the advances obtained.
What has been implemented in the information of the patients concerned by Nomestrol Acetate (Lotényl and its generics) and chlormadinone acetate (Lotéran and its generics)?
Since July 2021, a certificate of information on the risks of meningioma must be coined by the doctor and the patient before being able to go and get the medication at the pharmacy. This paper is necessary for the drug to be delivered.
We also asked that there is a letter. All the women who have taken Lotényl in the past two years, or Luteran, or their generics, we cannot go back further for data anonymization, will receive a letter from health insurance telling them that they must turn to their doctor and see with him the walk to follow. In the mail, it will be indicated that these drugs have a risk of developing meningioma and explained above all what a meningioma is.
Doctors also received, last November, a letter from health insurance and the ANSM informing them that they have patients who have taken these treatments and who are at risk. The procedure is indicated to them and they have the list of those concerned.
Why not ban these molecules?
These are treatments that are useful for many women. Over 1000 women who take these treatments, there are 1 which risks developing meningioma and 999 for which the treatment will be useful. Our goal is that they are prescribed when necessary and that women who take them are well informed of the potentially serious but rare risk. It is not a question of panicking women who take these treatments but that they take them with the maximum security, with full knowledge.
Now that alerts and studies have been done, what is shared information, what are you fighting today?
There is a lot of information work that is done but we try to make sure that fewer women pass between the stitches despite everything that is put in place. We also fight so that the word “Benin” is banished. This word, women no longer support it. The potential severity of meningiomas is not recognized. Not all are serious but it can destroy a life, lead to serious consequences. It is not taken into account the significant fatigue problems that we have almost all after being made, the problem of certain meningiomas so badly placed that the operation takes a vital risk so which are not operated and women remain with significant problems. There are many different cases but overall women can no longer tell them that it is nothing and that after three months they can return to work. This adds a load on what you experience. We would like it to be minimized.
