The ANSM is rolling out an unprecedented information campaign to 1.6 million users of desogestrel 75 µg (Cerazette, Optimizette, etc.) to prevent a low but real risk of meningioma.
A targeted, large-scale information campaign
Starting September 14, the ANSM will send individual letters to patients who have had at least one reimbursed prescription for desogestrel, while informing more than 90,000 health care professionals. The agency’s explicit objective is to foster a calm dialogue with doctors or midwives during upcoming consultations, without encouraging an abrupt cessation of treatment.
Derived from the 2024 work of the Epi-phare project, which analyzed more than 8,391 operated patients, the study shows that contraception with levonorgestrel is not implicated. By contrast, it highlights an excess risk of meningioma among women over 45 using desogestrel. This risk appears after five years of continuous use and increases after seven years, while remaining modest with an estimated incidence of one additional case for 17,000 women exposed beyond five years.
Disappearance of the excess risk after stopping
The ANSM notes that the impact of desogestrel remains far lower than that of other historic progestin therapies such as Androcur or Lutényl, whose risks proved to be up to twenty times higher. Additionally, the statistical excess incidence disappears one year after the end of treatment. And this is despite the fact that stopping the pill has no effect of reversing a tumor that has already formed.
Meningioma is a typically benign tumor of the meninges, and its development can lead to a variety of neurological symptoms such as chronic headaches, visual or motor deficits, balance problems, and seizures. Routine brain MRI is not recommended for the entire population on this medication; imaging is only indicated if symptoms appear or in individuals with a history of prolonged exposure to other at-risk progestins.
Limitations of this campaign
The postal mailings from the national health insurance do not reach all users exposed to related molecules. Non-reimbursed combined oral contraceptives and vaginal rings fall outside the outreach due to lack of traceability in public databases, although the risk cannot be ruled out there.
Meanwhile, the subcutaneous Nexplanon implant (etonogestrel), used by about 600,000 women, is not affected by these mailings. This product has not undergone a dedicated evaluation by the Epi-phare study, but health authorities nevertheless believe that the younger age profile of implant users should be associated with a substantially lower risk of meningioma.
