PRAC July 2026: new safety recommendations for desogestrel- and etonogestrel-containing contraceptives and Litfulo

During its July 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended 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 the risk

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) agreed on a direct healthcare professional communication (DHPC) to inform healthcare professionals about a small increased risk of meningioma associated with current, prolonged use (more than one year) of desogestrel- or etonogestrel-containing contraceptive 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 study. This study showed a small increased risk of intracranial meningioma in women using desogestrel for one year or longer, 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.