The European Medicines Agency (EMA) has recommended updating the product information for desogestrel- and etonogestrel-containing contraceptives to warn of a small increased risk of meningioma, a usually benign tumour of the tissue layer surrounding the brain and spinal cord. The recommendation, adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) at its 6-9 July 2026 meeting and published on 3 August 2026, adds meningioma to the contraindications, warnings, and undesirable effects sections of the summary of product characteristics and the package leaflet.
The update is based on a case-control study showing that current, prolonged use (≥1 year) of desogestrel 75 μg was associated with a small increased risk of intracranial meningioma requiring surgery (odds ratio 1.3, 95% CI 1.1-1.5). The risk increased with longer duration of treatment, reaching an odds ratio of 2.1 (95% CI 1.5-2.9) after seven or more years of use. The excess risk was greater in women who had previously used a progestogen with a known association to meningioma (odds ratio 3.3, 95% CI 2.6-4.1). The estimated number needed to harm was 67,300 women for one intracranial meningioma, and the increased risk was no longer observed one year after discontinuation.
For etonogestrel-containing products, the PRAC noted that since desogestrel is metabolised to etonogestrel, the study results are also of clinical relevance. The new wording instructs healthcare professionals to monitor patients for signs and symptoms of meningioma, such as changes in vision, hearing loss, loss of smell, headaches that worsen over time, memory loss, seizures, or weakness in arms or legs, and to discontinue treatment if a diagnosis is confirmed.
The recommendation applies to all desogestrel- and etonogestrel-containing products authorised in the EU. Marketing authorisation holders will need to adapt the wording to individual products, taking into account existing wording in some nationally authorised products. The PRAC's full recommendations, including general guidance on signal handling, are available on the EMA website.
This update adds to a series of safety signal assessments by the PRAC, which routinely reviews emerging safety data for authorised medicines. The committee's recommendations are forwarded to the European Commission for a binding decision, after which national authorities and marketing authorisation holders implement the changes.
The new information will affect women using these contraceptives, who may need to discuss the risk with their healthcare provider, and healthcare professionals, who will need to consider the risk when prescribing and monitor patients accordingly. For marketing authorisation holders, the update requires revising product information and may involve additional regulatory submissions. The change reflects a balance between providing important safety information and avoiding unnecessary alarm, given the small absolute risk and the established benefits of these contraceptives.