One Case per 67,300 Women: What the New Warning Means for You
HALMED and the EMA have issued a warning about a rare risk of brain tumors linked to long-term use of contraception containing desogestrel, but experts say there is no cause for panic.
HALMED and the EMA have issued a warning about a rare risk of brain tumors linked to long-term use of contraception containing desogestrel, but experts say there is no cause for panic.
The Croatian Agency for Medicinal Products and Medical Devices (HALMED) last week sent a warning to healthcare professionals about an increased, yet still extremely low, risk of a rare brain tumor, meningioma, associated with the long-term use of certain hormonal contraceptives. The warning specifically refers to the medication Novynette, the only such product currently approved in Croatia.
This concerns medications containing the active substances desogestrel or etonogestrel, hormones from the progestogen group. Although products with etonogestrel are not registered in Croatia, it is important to know that desogestrel is metabolized in the body into etonogestrel, so the new risk data applies to both substances.
In collaboration with HALMED and the European Medicines Agency (EMA), the manufacturer Gedeon Richter has sent a letter to physicians. A large French epidemiological study, which included more than 8,000 women operated on for meningioma and nearly 84,000 women without this diagnosis, served as the basis for this information. According to estimates, for approximately 67,300 women who use desogestrel long-term, one additional case of meningioma occurs. The duration of use increases the risk, especially after seven years of use.
Meningioma is a tumor that arises in the membranes surrounding the brain and spinal cord. Although it is benign in most cases, it can cause serious symptoms such as persistent headaches, changes in vision or hearing, loss of smell, epileptic seizures, or weakness in the limbs. Sometimes surgical removal is necessary.
The positive news from the study is that one year after stopping desogestrel, the increased risk was no longer observed. For women who have or have had meningioma, the use of these medications is now prohibited, and if such a diagnosis is made during therapy, treatment must be stopped immediately.
Prof. Dr. Velimir Šimunić, full professor of gynecology and obstetrics at the School of Medicine in Zagreb, believes that the new warning requires additional caution from doctors, but not alarm among patients.
"Such information can understandably cause concern, but it is important to emphasize that the risk is indeed extremely small. We are talking about approximately one case in more than 67,000 women, which is not a reason for panic. Every hormonal contraceptive should be prescribed individually, with an assessment of benefits and potential risks, and when other suitable options exist, the doctor will discuss them with the patient. Women who are concerned, especially if they have been taking this therapy for years, should contact their gynecologist to jointly assess whether it is necessary to continue with the same product or consider an alternative. With due caution, there is no room for panic," Šimunić said.
HALMED emphasizes that women should not stop taking contraception on their own initiative. The medication information will be updated to list meningioma as a side effect of unknown frequency. Healthcare professionals are encouraged to report any suspicion of this side effect through the OPeN system.
For women using this type of hormonal contraception, the most important message remains that there is no reason for panic. In the case of long-term use or the occurrence of symptoms such as persistent headaches, changes in vision or hearing, loss of smell, or epileptic seizures, it is recommended to consult a doctor. The decision to continue, change, or stop therapy should always be made in consultation with a gynecologist.
