The European Medicines Agency (EMA) issued new guidance last Friday on the safe use of certain widely used contraceptives, following an assessment of new scientific evidence by its Pharmacovigilance Risk Assessment Committee (PRAC).
The changes concern contraceptives containing the substances desogestrel or etonogestrel. The PRAC concluded that prolonged use, more than one year, of contraceptives containing either substance is associated with a small increase in the risk of meningioma, a tumour that develops in the tissue surrounding the brain and spinal cord.
Meningioma is in most cases a benign tumour, though depending on its size and location it can cause serious neurological problems.
The EMA said the overall risk remains very low, noting that based on available data, it is estimated to correspond to approximately one additional case of meningioma per 67,300 women using these medicines. Under the new recommendations, the use of contraceptives containing desogestrel or etonogestrel is now contraindicated in women who have, or have previously had, meningioma.
Doctors are also being asked to assess each patient’s history before starting treatment, particularly where other progestogens associated with an increased meningioma risk have previously been used. If meningioma is diagnosed during treatment, the medicine must be discontinued immediately.
Symptoms that require medical assessment
The EMA’s relevant committee recommends that women taking these contraceptives be informed of symptoms that could be related to meningioma, including:
- Changes in vision
- Hearing loss or tinnitus
- Loss of smell
- Persistent or worsening headaches
- Memory problems
- Seizures
- Weakness in the arms or legs
The appearance of such symptoms does not necessarily mean a meningioma is present, but requires immediate assessment by the treating doctor.
The EMA said the new recommendations do not change the positive benefit-risk balance of these medicines. Instead, according to the relevant statement, the aim is to improve information for doctors and patients, so that treatment decisions are made based on the most recent scientific evidence and an individualised risk assessment for each patient.