PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata.

• The PRAC recommends updated safety measures following evidence of a small increased risk of meningioma with prolonged use (more than one year) of desogestrel- and etonogestrel-containing contraceptives. Although the absolute risk remains very low (approximately one additional case per 67,300 users), these medicines are now contraindicated in women with a current or previous meningioma. Patients should be monitored for symptoms suggestive of meningioma, such as vision or hearing changes, persistent headaches, memory loss, seizures, or limb weakness. Treatment must be discontinued if meningioma is diagnosed. Product information will be updated to include this risk, and healthcare professionals will be informed through a Direct Healthcare Professional Communication (DHPC).

• The PRAC recommends strengthening the safety warnings for Litfulo (ritlecitinib) to align with those of other Janus kinase (JAK) inhibitors. A boxed warning will advise that Litfulo should only be used when no suitable alternatives exist in patients aged 65 years or older, those at increased cardiovascular or cancer risk, and current or former long-term smokers. Caution is also advised in patients with risk factors for venous thromboembolism. These updates are based on evidence from other JAK inhibitors and the similarity of Litfulo’s mechanism of action. The recommendation will be reviewed by the CHMP before being communicated to healthcare professionals and incorporated into the product information.