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testimony and brain tumor: “We eat poison!”, Alerts a Doubs patient
Affected by frontal meningioma, a 32 -year -old Doubs resident filed a complaint for "involuntary injuries" against the Theramex laboratory, which manufactures the Lotényl pill. His case echoes a recent study on this progestin drug, which establishes an increased risk of tumor in the brain. "All women must be aware," she alerts.
Are we heading for yet another sanitary controversy ? This is the conviction of Lucie*, 32, to whom a meningioma has just been diagnosed. This resident of the Doubs has no doubt: her tumor of the membranes surrounding the brain stems from a regular socket of Lutényl, current pill in our pharmacies, prescribed for various gynecological evils.
His fear seems to be supported by the National Medicines Safety Agency (ANSM) herself, which in June 2020 launched an alert on "an over-risk of meningioma". This alarm signal - very official - is based on a study carried out on Lotényl, the results of which were disclosed this summer.
Video. What to know about the risks linked to lutenyl
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"Not the only one in this case"
"We eat poison, no more, no less!" Lucie hammers who wants to hear it. "All the women who are taking it must be aware and go to consult their attending physician. I am not the only one in this case. There are other women who live with a tumor of 4 to 5 centimeters in their heads, and who do not even know it! ", She continues, determined to fight a fight that she knows in a trying advance.
Lucie filed a complaint on October 28 in Besançon for "involuntary injuries" and "aggravated deception" against X and against the Theramex laboratory, which manufactures Lotényl .
The laboratory? "I feel like they don't care"
"I had my arms that fell me. It's hard to cash. Even if these tumors are rarely carcinogenic, I am afraid of the next day because we do not know if it will not grow and compress the brain, "admits Lucie, exposed to possible neurological attacks. His file was entrusted to the expert hands of a teacher from the Lariboisière hospital in Paris. In the event of a negative development, the surgical option can be envisaged. It is often risky.
"For the info to go up," Lucie has attached to the pharmacovigilance cell of the Besançon CHRU, which returned a thick file to fill out. “I also called the Theramex laboratory to find out more. They only apologize, they can only say that, but I have the impression that they don't care, ”she gets carried away.
A “miracle” drug against endometriosis
“I suffered from endometriosis, abdominal pain 24 hours a day, ovarian cysts, hell. I was started to prescribe Lotényl in 2008 and, since then, no sign of the disease. I was reluctant, I was happy, ”says the thirty -something.
His daily life changes when reading an article on the Internet relaying the ANSM alert two months ago. "I spoke to my doctor, who made me pass an MRI control" ... The sentence is relentless: frontal meningioma.
A probable seizure of the public health center of the Paris prosecutor's office
On the civil and criminal level, several sensitive questions arise. What is proven causal? What responsibilities? What level of damage? “My client just wants to know and understand what it is. She knows that in 2016, she had no tumor since at the time, she had spent a first MRI for another reason. We can therefore wonder if the laboratory was aware, and if so, since when? e aloud , her lawyer.
Informed of the complaint of Lucie, the public prosecutor of Besançon, Etienne Manteaux, plans to divest himself for the benefit of the public health center of the Paris prosecutor's office. This section brings together magistrates experienced in this kind of sharp surveys, which are demanding leading time and medical knowledge.
"I want to fight for myself, but also for others"
In such circumstances, it also happens that the complainants turn against the ANSM , the gendarme of the drug. Has this organization alert under the supervision of the Ministry of Health this summer was too late, when Lotényl has been prescribed for many years?
Lucie is confused. At times, his morale vacillates. "My life is upset," she sighs, "as soon as I hurt my head, I wonder if it is because of my tumor. But I know that you have to move forward. I want to fight for myself and for others. »»
*(modified first name)
Long -term lutenyl: a risk of meningioma multiplied by 12.5
As early as 2019, an over-risk of tumor was established for Androcur, a drug prescribed against acne, endometriosis or as a contraceptive. A vast epidemiological study was therefore launched on its two "little brothers", Lotényl and Lutéran. In collaboration with Social Security, three million patients were asked for 2020.
The conclusions were unveiled in June. The risk is correlated with the duration of treatment , the dose absorbed and the age of the person . For the more common lutenyl a woman under treatment for six months multiplies by 3.3 the risk of developing meningioma. A figure that leaps to 12.5 from five years of treatment. For information, the “normal” probability of developing such a tumor is estimated at 8 out of 100,000 people.
A large public consultation was carried out on November 2, under the aegis of the National Agency for Medicines Safety (ANSM), live on YouTube. With one objective: to determine with precision the conditions under which Lotényl and Lotéran can be still prescribed, to "reduce this risk of meningioma".
Pending new decisions, the ANSM has renewed its recommendations with regard to healthcare professionals, namely informing patients of this risk, reassessing the risk of treatment and considering an MRI of control depending on the case. Patients are invited to take a clip with their attending physician to discuss this new deal.
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