EMA’s PRAC issues new safety warnings for desogestrel and etonogestrel contraceptives, citing a small increased risk of meningioma, and updates Litfulo (ritlecitinib) labeling to align with JAK inhibitor class risks. Updated prescribing information and DHPCs will follow across the EU.
Written By: Dr. Preethi Putti, PharmD
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has agreed on new safety communications affecting hormonal contraceptives containing desogestrel or etonogestrel and Litfulo (ritlecitinib), a Janus kinase (JAK) inhibitor approved for severe alopecia areata. The recommendations introduce additional risk minimization measures, updated prescribing information, and direct communications to healthcare professionals across the European Union.
New Meninigioma Warning for Desogestrel and Etonogestrel Contraceptives
PRAC concluded that prolonged current use of desogestrel- or etonogestrel-containing contraceptives for more than one year is associated with a small increase in the risk of intracranial meningioma, a usually benign tumor arising from the membranes surrounding the brain and spinal cord. Although most meningiomas grow slowly and are non-cancerous, they can cause significant neurological complications depending on their size and location.
The committee emphasized that the absolute risk remains very low, estimating approximately one additional case of meningioma for every 67,300 women using these medicines.
Following the review, PRAC recommended that desogestrel- and etonogestrel-containing medicines should no longer be used in women with an existing meningioma or a history of the condition. If a patient develops meningioma during treatment, the contraceptive should be discontinued immediately.
Healthcare professionals are also advised to monitor women receiving these medicines for symptoms suggestive of meningioma, including persistent or worsening headaches, vision changes, hearing loss or tinnitus, loss of smell, memory impairment, seizures, or weakness affecting the arms or legs.
The recommendations are based on findings from a large French epidemiological study showing that the risk increases with longer duration of desogestrel use. PRAC also noted that previous exposure to other progestogens already linked to meningioma, including cyproterone, nomegestrol, medroxyprogesterone, and chlormadinone, may further increase the risk and should be considered before initiating therapy.
Product information for desogestrel tablets and etonogestrel implants or vaginal rings will be updated to include meningioma as a side effect with an unknown frequency, alongside new contraindications and warnings.
Litfulo Safety Warnings Aligned with Other JAK Inhibitors
PRAC also endorsed updated safety information for Litfulo (ritlecitinib), strengthening warnings to reflect risks already established for other JAK inhibitors used in chronic inflammatory diseases.
Litfulo is approved for adults and adolescents aged 12 years and older with severe alopecia areata, an autoimmune disorder characterized by patchy or extensive hair loss. Ritlecitinib works by selectively inhibiting JAK3 and TEC kinases, reducing immune signaling involved in disease activity.
Based on evidence from clinical trials, published literature, post-marketing safety reports, and the known class effects of JAK inhibition, PRAC concluded that Litfulo should carry the same boxed warning as other medicines in this therapeutic class.
The updated labeling will recommend using Litfulo only when no suitable treatment alternatives are available in patients aged 65 years or older, those with an increased risk of major cardiovascular events such as heart attack or stroke, current or former long-term smokers, and patients at elevated risk of cancer. The committee also advised caution when prescribing the medicine to individuals with additional risk factors for venous thromboembolism.
Regulatory Path Forward
PRAC’s recommendation for Litfulo will now be reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the agency’s final position. Once approved, the updated prescribing information and Direct Healthcare Professional Communications (DHPCs) for both Litfulo and desogestrel- and etonogestrel-containing medicines will be distributed by the respective marketing authorization holders and published through EMA and national regulatory authorities across European Union member states.
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About the Writer
Dr.Preethi Putti, PharmD (LinkedIn) is a pharmaceutical researcher with experience in healthcare and pharmaceutical market research and competitive intelligence. She specializes in analyzing drug pipelines, clinical data, and industry trends and translating complex scientific data into clear and structured medical content. Strong foundation in clinical research, data interpretation, and evidence-based healthcare analysis. Committed to advancing a global career in clinical research and healthcare innovation.