Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 -9 July 2026.

During the July 2026 meeting, the PRAC adopted important recommendations regarding the safety of medicinal products, in particular:

Desogestrel- and etonogestrel-containing medicines: risk of meningioma: PRAC recommended new measures to minimize the risk of meningioma associated with the prolonged use (>1 year) of these medicinal products. Although this risk is considered very rare, their use is now contraindicated in women who have a meningioma or have had one in the past. In addition, new recommendations have been introduced for monitoring signs and symptoms suggestive of the condition and for discontinuing treatment if a diagnosis of meningioma is made. The product information will be updated to include new contraindications and warnings, as well as meningioma as a potential adverse reaction.

Litfulo (ritlecitinib): Safety warnings will be strengthened: PRAC recommended updating the product information and educational materials to align Litfulo’s safety warnings with those already established for other Janus kinase (JAK) inhibitors. A boxed warning will be introduced in the product information, recommending the use of the medicinal product only when no suitable therapeutic alternatives are available for patients aged 65 years or older, individuals at increased risk of major cardiovascular events or malignancies, and who smoke or have done so for a long time in the past. Particular caution is also recommended in patients with risk factors for venous thromboembolism.

For both issues, PRAC recommended the dissemination of a Direct Healthcare Professional Communication (DHPC) to inform healthcare professionals about the new risk minimisation measures and updates to the product information.

Further information is provided in the communication available under “Related Documents.”

Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to ensure the continuous monitoring of the safety of medicinal products and the protection of patient health.