Published on
Updated
Reading 1 min.
The ANSM published this Tuesday new European recommendations on drugs based on nomegestrol and chlormadinone.
This Tuesday, November 15, the ANSM alerted women to the increased risk of meningioma associated with drugs based on chlormadinone and nomegestrol acetate (Luteran, Lutenyl and generics).
Marketing authorizations will be modified
In accordance with the opinion issued by the European Medicines Agency, the marketing authorizations for these medicines will be subject to modifications:
- Medicines containing chlormadinone acetate (5 to 10 mg/tablet) or nomegestrol acetate (5 mg/tablet) should only be prescribed when other treatments are unsuitable.
- Medicines containing chlormadinone acetate or nomegestrol acetate, including in combination with an estrogen and at low doses, are contraindicated in patients with meningioma or a history of meningioma.
- Patients should be monitored for follow-up and detection of meningiomas, including brain imaging monitoring, for medicinal products containing 5 to 10 mg chlormadinone acetate per tablet or 5 mg nomegestrol acetate per tablet.
- If a meningioma is diagnosed in a patient treated with one of these drugs, the treatment should be stopped permanently and never prescribed again.
These drugs used against menstrual disorders, premenstrual syndrome, menopause and endometriosis indeed increase the risk of meningioma, a usually benign brain tumor that develops from the membranes that surround the brain.
This risk,increases with dose and duration of treatment use“, specifies the ANSM.
Therefore, this should be limited to the minimum dose and in the shortest possible time.