Around 1.6 million women who have taken a desogestrel-based contraceptive pill (brands Antigone, Cerazette, Elfasette, and Optimizette) will receive a personalized email to inform them, as a precaution, of the “very slight increase in risk” of developing meningioma, a tumor in the meninges, generally benign.
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This health alert in France was issued by the National Agency for the Safety of Medicines (ANSM), which has also sent letters to the 90,000 doctors or other healthcare professionals who have prescribed the pill.
In the note published by the ANSM, it tries to reassure those who have been treated with desogestrel to avoid pregnancy and indicates that “in the absence of symptoms, there is no need to schedule an urgent medical visit.” However, it is recommended to consult a doctor if symptoms compatible with a possible meningioma appear, such as persistent headaches, hearing loss, vision problems, speech difficulties, or balance issues, as well as muscle weakness, memory dysfunctions, or the onset or worsening of epilepsy.
“For most women, receiving this email will not require taking any particular action,” assures the drug agency. “They are invited to continue their contraception and not to stop it on their own initiative – adds the regulatory body -. A sudden stop without medical advice can lead to the risk of unwanted pregnancy.”
The ANSM reminds that contraceptive methods like desogestrel should be re-evaluated annually by the doctor or midwife, taking into account the woman’s age, the duration of treatment, and other factors. The agency emphasizes, to avoid unnecessary anxiety, that receiving the warning email “does not mean that a meningioma has been diagnosed or is suspected.”
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The French drug surveillance agency was forced to act as a result of a study conducted by Epi-Phare, the body that carries out and coordinates these drug and epidemic analysis projects. The results were analyzed at the European level and already led the European Medicines Agency (EMA) to recommend, last July, that the risk of meningioma be included among the product characteristics. Doctors were already informed.
According to the study, there may be one additional case of meningioma for every 67,000 women who have taken desogestrel pills for one year, or one for every 17,000 women who have taken it for five years. The risk increases in women over 45 years old or those exposed for more than five years. If the woman had previously taken a pregnancy-inducing medication with a risk of meningioma, containing components such as cyproterone acetate, nomegestrol, or chlormadinone, the risk may be significant from the first year of desogestrel intake. The potential danger of the drug disappears one year after stopping the treatment.
During a press conference to provide more details about the warning, Dr. Isabelle Yoldjian, medical director of the ANSM, reiterated that the meningioma risk detected with desogestrel has nothing to do with that of pregnancy inducers like Androcur, which multiplied the risk by twenty after five years of use.
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