Direct notices to doctors will warn that desogestrel- and etonogestrel-containing contraceptives carry a small added meningioma risk after more than 1 year of use, with about 1 extra case per 67,300 women.
Women with a current or past meningioma should no longer use those medicines, and treatment must stop if meningioma is diagnosed; labels will add the tumor as a side effect and list symptoms to monitor.
A large French epidemiological study drove the review, finding risk rose with longer desogestrel use and may be higher in women previously exposed to other progestogens already linked to meningioma.
Litfulo will also get stronger warnings, including a boxed warning limiting use in patients 65 or older or at higher risk of cardiovascular events, cancer or long-term smoking-related harm when alternatives exist.
PRAC said Litfulo's warning changes align it with other JAK inhibitors after reviewing trials, literature and post-marketing reports; the recommendation now goes to EMA's CHMP for adoption.