Two Medicine Safety Updates: Meningioma Risk and Falsified DARZALEX — 12 August 2026
- 12-08-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
PharmExpert’s pharmacovigilance monitoring identified two important medicine-safety topics requiring attention.
Desogestrel and etonogestrel: meningioma risk
European national regulators have issued direct healthcare professional communications on a small increased risk of meningioma with current prolonged use (one year or longer) of desogestrel- and etonogestrel-containing contraceptives. The estimated excess risk is approximately one additional case per 67,300 women treated with desogestrel.
These medicines are contraindicated in patients with a current or previous meningioma. Patients should be monitored for symptoms, treatment should be stopped if meningioma is diagnosed, and product information and package leaflets are being updated.
Importance: High. The communications introduce a newly established risk, contraindication, monitoring measures and safety-related labelling changes.
Official sources: ANSM, AIFA, BfArM, CBG-MEB, HPRA.
WHO Medical Product Alert N°3/2026: falsified DARZALEX
WHO has warned about falsified DARZALEX (daratumumab) injection identified in the Maldives and Mexico. The affected products are batch STV1K01, 400 mg/20 mL, expiry 05/2029, and batch MYS7381, 100 mg/5 mL, expiry 03/2029.
The contents, quality and sterility are unknown; visible particles were identified in batch STV1K01. Potential consequences include contamination, infection, injection complications, treatment failure, disease progression, morbidity and mortality. The falsified products must not be used. Suspected adverse events, lack of effect and quality defects should be reported to the relevant regulator or pharmacovigilance centre.
Importance: Critical. The quality defect and falsification have a documented connection to patient harm, lack of efficacy and mortality.
Official sources: WHO alert, WHO PDF, Uzbekistan Center confirmation.
This publication summarises official regulatory information and does not replace medical advice or approved product information.