Desogestrel-based drugs: limited monitoring in the face of risks deemed low

Patients taking a pill containing desogestrel (Optimizette, Cerazette, etc.) will not need a routine MRI, the drug agency announced on Thursday, stressing that the risks of brain tumors remain very low compared to other progestins.

"Given the low risk, the French National Agency for the Safety of Medicines (ANSM) does not recommend routinely performing a brain MRI" for women taking desogestrel, Isabelle Yoldjian, medical director of the health authority, told AFP.

The ANSM recommends an MRI "only for women presenting signs suggestive of meningioma" (such as persistent headaches, visual or speech disorders, etc.) or at the start of treatment with desogestrel, in the event of prior use "for more than one year" of "one or more risky progestins."

The agency is thus supplementing recommendations issued at the end of 2024 following a study by the Epi-Phare scientific interest group which assessed the risk of meningioma (a brain tumor which does not lead to death but can cause serious after-effects) associated with taking desogestrel.

Based on the results of this study, this risk is very low and concerns women over 45, or those taking this contraceptive for more than five years.

In contrast, monitoring by brain imaging is systematically recommended for progestins with a significant risk of meningioma (Androcur, Lutényl, Lutéran, Colprone and Depo Provera).

Pills containing desogestrel are marketed under the names Optimizette, Cérazette, Antigone, Lactinette, Elfasette, Clareal, Desopop and generic versions.

The agency added in its press release that it will approach the European Medicines Agency (EMA) to include the risk in the leaflets for these pills.

Its recommendations for desogestrel 75 µg also apply to combined pills containing desogestrel 150 µg and to the contraceptive implant Nexplanon, which contains an active derivative of desogestrel.

They will be emailed to healthcare professionals "in the coming weeks."

The ANSM also issued a warning regarding contraception for women, especially after the age of 45. It reiterated the importance of "reassessing the benefits of continuing or changing contraception, regularly every year, in light of the woman's age, medical history, lifestyle, and choices, and this until the age of menopause."

Desogestrel should not be used as a hormonal treatment for menopause, the agency reminds.