The European Medicines Agency (EMA) issued new guidelines for the safe use of certain widely used contraceptives last Friday, following an evaluation of new scientific evidence by the Pharmacovigilance Risk Assessment Committee (PRAC).
The changes concern contraceptives containing the substances desogestrel and etonogestrel.
Specifically, the PRAC concluded that prolonged use (more than one year) of contraceptives containing one of the two substances is associated with a slight increase in the risk of developing meningioma, a tumour that develops in the tissues surrounding the brain and spinal cord.
It is emphasized that meningioma is in most cases a benign tumour, however, depending on its size and location, it can cause serious neurological problems.
The EMA, clarifying that the overall risk remains very low, informs that based on the available data, it is estimated that it corresponds to approximately one additional case of meningioma per 67,300 women who use these drugs.
With the new recommendations, the use of contraceptives containing desogestrel or etonogestrel is contraindicated in women who have or have had meningioma in the past.
At the same time, doctors are asked to evaluate the history of each patient before starting treatment, especially if there has been a previous use of other progestogens that have also been associated with an increased risk of meningioma.
If meningioma is diagnosed during treatment, the drug should be stopped immediately.
Symptoms that need medical evaluation
The competent EMA Committee recommends that women taking these contraceptives be informed about symptoms that could be related to meningioma, such as:
Changes in vision
Hearing loss or tinnitus
Loss of smell
Persistent or worsening headaches
Memory disorders
Seizures
Weakness in the arms or legs
The appearance of such symptoms does not necessarily mean that there is a meningioma, however, it requires immediate evaluation by the attending physician.
The EMA points out that the new recommendations do not change the positive benefit-risk balance of these medicines.
On the contrary, as pointed out in the relevant announcement, the aim is to better inform doctors and patients, so that treatment decisions are made based on the latest scientific data and an individualized risk assessment for each patient.
Hearing loss or tinnitus
Loss of smell
Persistent or worsening headaches
Memory disorders
Seizures
Weakness in the arms or legs
The appearance of such symptoms does not necessarily mean that there is a meningioma, however, it requires immediate evaluation by the attending physician.
The EMA points out that the new recommendations do not change the positive benefit-risk balance of these medicines.
On the contrary, as pointed out in the relevant announcement, the aim is to better inform doctors and patients, so that treatment decisions are made based on the latest scientific data and an individualized risk assessment for each patient.
