France’s National Agency for Medicines and Health Products Safety (ANSM) has warned 1.6 million women who have used desogestrel-based contraceptives, including Antigone, Cerazette, Elfasette and Optimizette, about a low increased risk of meningioma. Affected women will receive letters explaining the concern.
ANSM also plans to notify approximately 90,000 doctors who have prescribed these contraceptives.
Women should consult a doctor if they develop persistent headaches, vision changes, muscle weakness, balance or speech difficulties, memory loss, or new or worsening epileptic seizures. A brain MRI may be requested if symptoms warrant further investigation.
Risk rises with prolonged use
Meningiomas develop in the meninges, the membranes surrounding the brain and spinal cord. They are usually benign but can cause serious neurological problems depending on their size and location.
A 2024 study by the Epi-Phare public-interest research group found that one in 67,000 women who had taken desogestrel developed a contraceptive-linked meningioma. After five years of treatment, the estimated risk increased to one in 17,000.
The risk more than doubled after seven years of use compared with women who had never taken the contraceptive. It appears to disappear one year after treatment stops. Women over 45 and those who previously used a high-risk progestogen for more than a year are considered especially vulnerable.
Even so, ANSM says the risk remains far lower than that associated with progestogens including Androcur, Lutényl, Lutéran, Colprone and Depo-Provera, for which routine brain imaging is recommended.
“This risk is low and is not comparable with that linked to Androcur, which was 20 times higher after five years,” said Isabelle Yoldjian, ANSM’s medical director.
Do not stop contraception without medical advice
ANSM advises women not to stop taking these contraceptives without consulting a doctor, gynaecologist or midwife. The agency recommends discussing the risk during the next appointment.
It also reminds women that the suitability of any contraceptive should be reviewed annually in light of their health and individual needs.
At ANSM’s request, the European Medicines Agency approved updates this summer adding the risk of meningioma to the patient information leaflets for these medicines.
