Illustration of a contraceptive pill pack -
In June 2020, an epidemiological study revealed an increased risk of developing a meningioma for women treated with Lutéran and Lutényl, two progestin-only pills used by approximately 600,000 women in France.
In September, the ANSM launched a public consultation and organized public hearings of patients to see in which cases these treatments were prescribed.
retraces these few months of health democracy by giving the floor to the head of the gynecology center of the ANSM and to one of the patients auditioned.
The investigation will have taken six months, but the recommendations are likely to significantly change their use.
After having alerted in June 2020 on the risk of meningioma (most often benign brain tumor) for women who take Lutéran (whose active molecule is chlormadinone acetate) and Lutenyl (nomegestrol acetate), two drugs very common progestins, the National Medicines Safety Agency (ANSM) unveils its new recommendations on Tuesday.
In the meantime, the Agency has called on caregivers, patient associations, researchers and women concerned to stick as closely as possible to the field.
What indications and what follow-up?
Result: the ANSM clearly limits the indications.
These pills should no longer be prescribed for menopause, menstrual cycle irregularities, premenstrual syndrome, mild mastodynia (breast pain) and contraception.
On the other hand, the benefit / risk balance was considered favorable in the event of endometriosis, functional hemorrhages, menorrhagia (very heavy periods) related to fibroids and severe mastopathy (non-cancerous breast disease).
"For Lutéran and Lutényl, the marketing authorizations (AMM) date respectively from 1973 and 1984," specifies Isabelle Yoldjian, head of the gynecology department at ANSM.
However, they are widely used with, in a good number of cases, a relative deviance from the wording of the MAs.
It was important to clean up these indications.
How many women would be affected?
The work of the ANSM did not make it possible to obtain exhaustive figures, but “we know that in 2019, approximately 200,000 women had taken Lutényl (or generics) at least once and 240,000 Lutéran (or generics) .
Suffice to say that these new recommendations, if followed, may cause sales to fall.
“Between August 2018 and August 2020, we have a drop in prescriptions of 30% for Lutényl and 50% for Lutéran”, continues Isabelle Yoldjian.
Second issue: what will be the follow-up for the patients?
Here again, the recommendations deviate significantly from what has been in effect until now.
“In June, we recommended doing magnetic resonance imaging (MRI) from 35 years old.
There, we removed the age barrier, she emphasizes.
All women should have a brain MRI after one year of treatment.
Then the patient is encouraged to do another MRI five years after the first imaging.
Then every two years.
Why this acceleration?
"If you take the treatment for three or four years, the risk is less than eight years," explains Isabelle Yoldjian.
The longer one is treated, the more close monitoring is required.
And of course, all patients should perform this test at any time during or after treatment for signs suggestive of meningiomas (headache, speech, vision, memory impairment, paralysis, dizziness).
"It was presented to me as the miracle solution"
To avoid missing out on an important topic, patients have been able to give their opinion on these treatments over the past few months.
In particular via a call for testimonials (which received 500 contributions) and six public hearings of patients with different profiles.
Véronique, 30, is one of the patients consulted.
After being diagnosed with endometriosis at the age of 28, and suffering martyrdom, she took Lutéran for nine months, then Lutényl for one year.
“It was presented to me as the silver bullet,” she explains.
And it's true that it helped me with the pain.
But the side effects were very important: acne, weight gain, depressive symptoms… ”In June 2020, following the alert from the ANSM, his surgeon advised him to stop immediately.
"It's a shame to think that doctors and researchers were aware of the risks and that I learned it from the press," she regrets.
So when the Endofrance association warns that the ANSM is looking for testimonies, it offers itself.
“I'm not saying that all women have a bad experience with Lutéran, but I did.
I was so sensitive that I could cry if someone didn't pass me the salt at the table!
When I complained about having gained 12 kg, I was told that maybe I was eating too much?
"On November 2, during the public hearings (in video, Covid-19 obliges), Véronique could not listen to all the testimonies," so they (her) 'destabilized.
Some stories are dramatic.
One of the patients had undergone invasive brain surgeries.
All this to better live the menopause… ”
Not "a common pill"
The words of the patients reserved a few surprises for the committee's experts.
In particular on the use of these treatments as contraception.
“Following the release of the first article in
, many women responded to our call for testimonials and thought that their treatment was a banal pill, is surprised Isabelle Yoldjian.
The public hearings turned out to be particularly interesting on this aspect.
Hence the slogan that the agency wishes to pass: "In contraception, there is no need to authorize this treatment insofar as there are alternatives", she insists.
The same goes for menopause.
“The risk of meningioma increases with age.
We therefore come up against a very significant impact if we combine this risk with the use of a drug that gives meningiomas.
The second thing that came out of the hearings was the lack of information available to women.
Health professionals are not aware or do not pass on the information, which is recent, it is true.
These testimonies encouraged us to send an email to health professionals in November ”.
How to improve information for patients?
The agency intends to go further.
A final committee meeting is scheduled for January 22 to find out how caregivers and women can get the right information.
For Androcur (another progestin that had been the subject of a public consultation), the Agency had put in place a certificate: when prescribing, the caregiver and patient had to sign a document specifying that the latter was aware of the risk. incurred.
Which certificate is mandatory to buy Androcur.
Will this be the case?
The question remains to be decided.
“What we know is that an information letter will be sent to all patients who receive Lutéran and Lutényl”, reveals Isabelle Yoldjian.
Véronique hopes that this public consultation will allow “to inform patients much better.
Most of the testimony I heard spoke of this lack of warning.
We often put forward the question of benefit / risk, but we hear little about it in a gynecologist's office!
And beyond these progestin-only pills, care should be taken to inform the patient when given a new treatment.
Pill: "Women who have taken Lutéran or Lutényl must check that they do not have neurological symptoms", explains Isabelle Yoldjian, of the ANSM
For the ANSM, certain progestin drugs increase the risk of brain tumors