Tavneos drug recalled in Hungary following EU safety concerns

The Hungarian National Public Health and Pharmaceutical Center (NNGYK) has ordered the immediate recall of all batches of the prescription drug Tavneos from pharmacies and hospitals. The medication was used to treat adults with rare and serious autoimmune conditions, specifically granulomatosis with polyangiitis and microscopic polyangiitis.

The recall follows a decision by the European Commission to withdraw the product's marketing authorization. Investigations by the European Medicines Agency (EMA) revealed serious irregularities in the clinical trials used to prove the drug's efficacy, rendering the data unreliable. Furthermore, findings indicated that the drug could increase the risk of liver damage and vanishing bile duct syndrome, which can be fatal.

Health authorities have issued a critical warning to patients currently undergoing treatment with Tavneos: do not stop taking the medication abruptly, as sudden interruption of therapy can be dangerous. Patients are urged to contact their treating physicians immediately to arrange for a safe transition to an alternative therapy.