HALMED: Novynette Carries Elevated Risk of Brain Tumors
It is estimated that for every 67,300 women treated with desogestrel, there may be approximately one additional case of meningioma.
It is estimated that for every 67,300 women treated with desogestrel, there may be approximately one additional case of meningioma.
On August 7, 2026, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) issued a letter to healthcare professionals warning of an association between contraceptive medications containing desogestrel or etonogestrel and an increased risk of developing meningioma, a tumor of the meninges. The warning directly applies to the medication Novynette, the only such product currently approved in the Republic of Croatia.
The letter was issued in collaboration with the marketing authorization holder, Gedeon Richter Plc., and pertains to medications used for contraception, either alone or in combination with ethinylestradiol. In Croatia, only Novynette is approved, at a dose of 0.020 mg ethinylestradiol and 0.150 mg desogestrel, while medications containing etonogestrel are currently not on the market.
According to estimates cited in the warning, the risk is described as small but statistically elevated. It is estimated that for every 67,300 women treated with desogestrel, there may be approximately one additional case of meningioma. The elevated risk is associated with use of the medication for one year or longer.
Due to these findings, the use of desogestrel or etonogestrel is now explicitly contraindicated in women who have been diagnosed with meningioma or have a history of it. Healthcare professionals are advised to regularly monitor women using these medications for potential signs and symptoms that could indicate a meningioma.
The warning specifically highlights that the risk may be further elevated in women who have previously used certain types of progestogens for which an association with meningioma has already been established. These include cyproterone, nomegestrol, medroxyprogesterone, and chlormadinone. Therefore, healthcare professionals are recommended to consider the patient's full history of hormonal therapy before prescribing medications with desogestrel or etonogestrel.
If a meningioma is diagnosed during use of the medication, therapy should be discontinued immediately. HALMED and EMA also remind all healthcare professionals of their legal obligation to report any adverse drug reactions, as well as quality defects. Patients who notice any side effects can report them directly to HALMED, but they are advised to first consult their doctor or pharmacist about any changes in their health condition for guidance on continuing therapy.
