PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata
Desogestrel- and etonogestrel-containing medicines: risk of meningioma and new measures to minimise this risk
PRAC agreed on a direct healthcare professional communication (DHPC) to inform healthcare professionals about a small increased risk of meningioma associated with current, prolonged use (>1 year) of desogestrel- or etonogestrel-containing contraceptives medicines. Although the risk is increased in people using these medicines, the overall likelihood of developing meningioma remains very low and one additional meningioma is estimated to occur for every 67,300 women who use the medicines. Meningiomas are tumours of the tissue layer surrounding the brain and spinal cord. Usually they are benign (non-cancerous) and grow slowly but, depending on the size or location, they can cause serious problems.
Use of desogestrel- or etonogestrel-containing medicines is now contraindicated in women who have a meningioma or have had one in the past. Women receiving these medicines should be monitored for signs and symptoms suggestive of meningioma, including changes in vision, hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures or weakness in arms and legs.
PRAC issued these recommendations following the review of data from a large French epidemiological study1. This study found a small increased risk of intracranial meningioma in women using desogestrel for one year or more, with the risk increasing with longer duration of use. In addition, the risk may be higher in women who previously used progestogens already associated with meningioma (for example cyproterone, nomegestrol, medroxyprogesterone, and chlormadinone). Previous progestogen use should therefore be considered before starting desogestrel or etonogestrel.
If a woman using desogestrel or etonogestrel is diagnosed with meningioma, use of the medicine must be discontinued.
Desogestrel and etonogestrel are progestogens used for contraception. Desogestrel-containing medicines are available as oral tablets, while etonogestrel-containing medicines are available as implants or, in combination with ethinylestradiol, as vaginal rings. The product information for these medicines will be updated to include meningioma as a side effect with a frequency “not known”, together with new contraindications and warnings.
The DHPC for desogestrel- and etonogestrel-containing medicines will be disseminated to healthcare professionals by the marketing authorisation holders, according to agreed communication plans, and published on EMA’s Direct healthcare professional communications page and in national registers in EU Member States.
Litfulo (ritlecitinib): update to product information to revise warnings in line with other Janus kinase inhibitors
PRAC agreed on a DHPC to inform healthcare professionals that the warnings on the potential risk of certain serious side effects with the Janus kinase (JAK) inhibitor Litfulo will be strengthened. The updated warnings are being introduced because other JAK inhibitors have an increased risk of serious side effects, including cardiovascular problems, blood clots, cancer and serious infections, and this increased risk is also considered to apply to Litfulo.
A boxed warning will be added to the Litfulo product information, stating that the medicine should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past and those at increased risk of cancer. In addition, Litfulo should be used with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism), other than those listed above.
Litfulo is a medicine used to treat adults and adolescents over 12 years of age with severe alopecia areata, an autoimmune disease causing hair loss of the scalp or other parts of the body. The active substance in Litfulo, ritlecitinib, works by blocking the action of certain enzymes called JAK3 and TEC kinases, which play an important role in inflammation.
The boxed warning is already included in the product information for other JAK inhibitors, which are used to treat certain chronic inflammatory disorders, including alopecia areata. For Litfulo, the PRAC reviewed available data from clinical trials, the literature and spontaneous post‑marketing reports of suspected side effects. Based on this review and considering that Litfulo also works by inhibiting a JAK enzyme, the PRAC concluded that the product information and educational material for Litfulo should be amended to include the same information as for other JAK inhibitors.
The PRAC recommendation for Litfulo will be forwarded to EMA’s human medicines committee (CHMP) which will adopt the Agency’s position. Once adopted, it will be disseminated to healthcare professionals by the marketing authorisation holder according to an agreed communication plan and published on the Direct healthcare professional communications page and in national registers in EU Member States.
References:
1. Roland N, Kolla E, Baricault B, Dayani P, Duranteau L, Froelich S et al. Oral contraceptives with progestogens desogestrel or levonorgestrel and risk of intracranial meningioma: national case-control study. BMJ 2025; 389:e083981 doi:10.1136/bmj-2024-083981
