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women called to testify



After warning about the risk of meningioma, a brain tumor, in women taking Lutéran or Lutényl, the Medical Products Agency opens a public consultation and urges patients to express themselves until 30 September. These pills are administered especially during menopause or in cases of endometriosis.

[Mise à jour le mercredi 23 septembre à 12h11] The Medical Products Agency launches one public consultation on drug use Lutéran® (chloromadinone acetate) and Lutényl® (nomegestrol acetate) in women compared to risk of meningioma was demonstrated in several patients. After an initial warning in February 201

9, the Medical Products Agency warned again risk of meningioma in connection with the use of these treatments and their generics, in a press release dated 17 June 2020. Organized on 2 November and broadcast live on the ANSM YouTube channel, this consultation aims to establish appropriate conditions for the use of Lutényl® and Lutéran® with respect to on the risk of meningioma, so that women for whom these treatments are eligible can continue to benefit from them. The consultation will take place in the form of written contributions and public hearings conducted by a committee of independent experts. This committee consists of doctors and associates and will give an opinion to the ANSM at the end of the consultation.

→ If at this time you want to express your opinion or share your experiences, as an individual or as part of an organization, you are invited to submit an online application between Thursday 10 and Wednesday 30 September 2020.

Lutéran® and Lutényl® are only progestin medicines for women. A progestin is a hormone that is naturally secreted in the middle of a woman’s menstrual cycle. It promotes the implantation of the egg in the uterus therefore pregnancy. But taken during the bike, it has the opposite effect. It thickens the uterine walls, which can no longer receive the egg. This is why this substance is used in the manufacture of only progestin pills or hormonal IUDs. Used alone or in combination with estrogen, it acts as a contraceptive. Lutéran® and Lutényl® can be indicated for irregular menstrual cycles, menstrual disorders and painful periods, of chest pain, artificial cycle in conjunction with an estrogen,endometriosis, bleeding related to fibroids.

> See the Lutheran leaflet

> See the leaflet Lutényl

Meningioma is one tumor, usually benign, which develops from the surrounding membranes brain and that spine (brains). The EPI-PHARE study, set up by ANSM and Cnam, confirms the increased risk of meningioma in women exposed to these macroprogestogenic drugs and highlights a significantly increased risk with the dose used, the duration of treatment and the age of the patient.

Women treated for more than 6 months with nomegestrol acetate or chloromadinone are exposed to a risk multiplied by 3.3 and 3.4 respectively compared to the baseline risk, then no later than 12.5 from a cumulative dose equivalent 5 years of treatment for nomegestrol acetate and with 7 from a cumulative dose corresponding to 3.5 years of use of chloromadinone acetate.

→ The risk of meningioma leading to intracranial surgery increases sharply with age : it is 3 times higher for women aged 35 to 44 than between the ages of 25 and 34 years.

The Medical Products Agency recommends:

  • If you are currently being treated with nomegestrol acetate (Lutenyl and generics) or chloromadinone acetate (Lutéran and generics), contact your doctor to discuss your treatment.
  • If you are over 35 years of age and have been treated with nomegestrol acetate (Lutenyl and generics) or chloromadinone acetate (Lutéran and generics) for more than 5 years, your doctor may suggest that you have a brain scan (MRI);
  • If you are being or have been treated with nomegestrol acetate (Lutenyl and generics) or chloromadinone acetate (Lutéran and generics) and you have symptoms that indicate meningioma (frequent headaches, vision problems, or hearing, dizziness, memory problems, etc.), contact your doctor who will to prescribe brain imaging (MRI);
  • If you have any further questions, ask your doctor.

The Medical Products Agency recommends that professionals:

  • Inform their patients about the risk of meningioma;
  • Re-evaluate the relevance of treatment with nomegestrol acetate or chloromadinone acetate, taking into account the individual risk;
  • Limit the use of these drugs as well as their doses to the lowest effective doses (cumulative dose effect);
  • Do not substitute macroprogestogens between them (nomegestrol acetate, chloromadinone acetate and cyproterone acetate) for history of meningioma or meningioma.
  • Have an MRI brain performed for symptoms suggestive of meningioma.
  • Offer to women over 35 years of age for long-term treatment (from 5 years), brain imaging with MRI.

Sources:

ANSM press release, Lutényl / Lutéran and the risk of meningioma: invitation to participate in a public consultation – Information point, 10 September 2020.

ANSM press release, Lutényl / Lutéran and generics: preliminary recommendations after confirmation of the increased risk of meningioma – Point d’Information, 17 June 2020


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