Brussels, 10 July 2026 — The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency today reached new consensus on the safety of two types of medicines and introduced risk management measures, involving desogestrel- and etonogestrel-containing contraceptives, as well as the alopecia areata drug Litfulo.
Contraceptives: Meningioma Risk Confirmed
The committee confirmed that long-term use (over one year) of desogestrel- or etonogestrel-containing contraceptives is associated with a small increased risk of meningioma. Although the absolute risk is very low (one additional case estimated per 67,300 users), preventive measures are being taken:
Contraindication: Not to be used in women with a history of meningioma
Monitoring: Watch for changes in vision, hearing loss, worsening headaches, seizures, and other symptoms
Discontinuation: Must stop immediately upon diagnosis of meningioma
Labeling: Meningioma to be added as a side effect
The decision is based on a French epidemiological study, which found that the risk increases with longer duration of use and is higher in women who have previously used progestogens such as cyproterone.
Litfulo: Boxed Warning Upgraded
The committee determined that, due to its mechanism of action being similar to other Janus kinase inhibitors, Litfulo carries risks of cardiovascular problems, thrombosis, cancer, and serious infections. A boxed warning will be added to the product information:
It is recommended that the medicine be used only when no suitable treatment alternatives are available for patients aged 65 years or older, those at high cardiovascular risk, smokers, or those at high risk of cancer. Caution is also advised for patients with thrombotic risk factors.
Analysts noted that these adjustments reflect the regulator's prudent balance between traditional drugs and new medicines in safety monitoring. Clinicians are advised to more systematically assess patient medical history and risk factors before prescribing.
