Nomestrol and chlormadinone and meningioma acetate: measures throughout Europe to limit the risk

By decision of October 28, 2022, the European Commission asked the European Union member states to modify the marketing authorizations of nomigestrol and ChlormaDinone medicines, following the reassessment of their profit/risk in accordance with the opinion rendered by the European Agency for Medicines:

• Medicines containing chlormadinone acetate (5 to 10 mg/tablet) or nomigestrol acetate (5 mg/tablet) are indicated only when other treatments are inappropriate. With these drugs, the risk of developing meningioma increases with the dose and the duration of use of the treatment. This must therefore be limited to the minimum effective dose and the shortest possible duration.
• Medicines containing chlormaudinone acetate or nomestrol acetate, including in combination with an estrogen and low doses, are contraindicated in patients with meningiom or a history of meningioma.
• Patients must be monitored for monitoring and detection of meningiomas in accordance with clinical practice, in particular monitoring by brain imaging for drugs containing 5 to 10 mg of chlormadinone acetate per tablet or 5 mg of nomestrol acetate per tablet.
• If meningioma is diagnosed in a patient treated by one of these drugs, the treatment should be stopped definitively and never be prescribed to the patient (contraindication).

This European re-evaluation of profit/risk had been requested in September 2021 by the ANSM after the publication of two French epidemiological studies, which confirmed a dose-dependent association between the use of chlormadinone or nomestrol and the risk of meningioma.

We recall that in July 2022 we expressed our reserve on the overall European conclusions for women than those that we have set up in France since January 2021 .
In particular, we consider that the benefit/risk of nomegestrol 5 mg acetate and chlormadinone acetate (5 and 10 mg) is negative in the following indications: menopause, artificial cycle in combination with an estrogen, cycle irregularities, premenstrual syndrome, non -severe breasts (mastodynia), contraception .

The monitoring recommendations that we issued in January 2021 remain unchanged for patients treated in France by Lotényl (Chlormadinone acetate) and Lutéran (Nomestrol Acetate) . The same applies to prescription and issuance conditions: when the processing by these drugs is continued beyond one year, an annual information certificate must be signed by the patient and her prescribing doctor and the dispensation of these drugs is possible only on presentation of a copy of this certificate.