France's medicines regulator, the Agence nationale de sécurité du médicament (ANSM), has launched a nationwide alert over a small but significant risk of brain tumours linked to a widely used class of contraceptive pills. Starting this week, around 1.6 million women who have taken desogestrel-based contraceptives – sold under brand names such as Antigone, Cerazette, Elfasette and Optimizette – will receive a letter detailing the potential danger and advising them on what to do.
The letters follow a review of epidemiological data that found a higher incidence of meningioma, a usually benign tumour of the membranes surrounding the brain, among women who have used these pills. The ANSM stresses that the absolute risk remains low, but it is enough to warrant a precautionary notification. In parallel, some 90,000 doctors who have prescribed these contraceptives are being informed so they can discuss the issue with patients.
What women should watch for
The agency is urging women who have taken desogestrel to seek medical advice if they experience persistent headaches, visual disturbances, muscle weakness, balance or speech problems, memory loss, or new or worsening epileptic seizures. In such cases, a doctor may recommend an MRI scan of the brain to rule out a meningioma.
The risk appears to increase with the duration of use. According to a 2024 study by the Epi-Phare research group, which links French health data, about one in 67,000 women who have ever used desogestrel develops a meningioma attributable to the drug. After five years of continuous use, that figure rises to one in 17,000. Seven years of use doubles the risk compared with non-users, but the risk returns to baseline within a year of stopping the pill.
Women over 45 and those who have previously taken other high-risk progestogens for more than a year are particularly affected. However, the danger is far smaller than that associated with older progestogen-only contraceptives such as Androcur (cyproterone acetate), Lutényl, Lutéran, Colprone or Depo Provera, for which routine brain imaging is already recommended.
“This risk is low, and bears no comparison with that of Androcur, which was 20 times higher after five years,” said Isabelle Yoldjian, ANSM’s medical director.
The agency is clear that women should not stop their contraception abruptly without speaking to a healthcare professional. Instead, they are encouraged to raise the issue at their next appointment with a doctor, gynaecologist or midwife. The ANSM also reminds all women that any contraceptive method should be reassessed annually, taking into account individual needs and health status.
The European Medicines Agency (EMA) approved an update to the patient information leaflets for these contraceptives this summer, adding meningioma as a potential side effect. The French notification is part of a broader European effort to ensure that women are fully informed about the risks and benefits of hormonal contraception.
While the news may cause concern, experts emphasise that the benefits of reliable contraception generally outweigh the small risk for most women. The key is informed choice and regular medical follow-up. For those who have used desogestrel and are worried, a conversation with a healthcare provider is the first step – not panic.
