France’s medicines safety agency has warned women taking desogestrel-based contraceptives about a small increased risk of developing meningioma and advised them to seek medical advice if they develop certain symptoms.
The National Agency for Medicines and Health Products Safety (ANSM) said around 1.6 million women in France who have taken contraceptives containing desogestrel will receive letters informing them about the potential risk. About 90,000 healthcare professionals who have prescribed the medicines will also be notified.
The contraceptives affected include Antigone, Cerazette, Elfasette and Optimizette.
ANSM stressed that the risk remains low but advised women to contact a doctor if they experience persistent headaches, visual problems, muscle weakness, balance or speech difficulties, memory loss, or the appearance or worsening of epileptic seizures.
Doctors may recommend a brain MRI if symptoms raise concerns about a possible meningioma.
A meningioma is a tumour that develops from the membranes surrounding the brain and spinal cord. Most are benign, although they can cause serious neurological problems depending on their size and location.
Research by the Epi-Phare public interest research group, published in 2024, estimated that one woman in 67,000 who had taken desogestrel developed a meningioma associated with the contraceptive. After five years of treatment, the rate increased to about one in 17,000.
The research found that the risk was twice as high after seven years of treatment compared with women who had not taken desogestrel. However, the increased risk was reported to disappear within a year after treatment ended.
Women aged over 45 and those who have previously taken a high-risk progestogen for more than a year are considered to be at greater risk.
ANSM said the risk associated with desogestrel remains substantially lower than that linked to certain other progestogens, including Androcur, Lutényl, Lutéran, Colprone and Depo Provera. These medicines have stricter monitoring recommendations involving brain imaging.
“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 urged women not to stop taking their contraception without first consulting a healthcare professional. It recommended discussing the treatment with a doctor, gynaecologist or midwife and reassessing contraceptive needs annually.
The European Medicines Agency approved the addition of information about the meningioma risk to patient leaflets for desogestrel contraceptives following a request from ANSM.
