Rare disease drug recalled in Ireland after Japan deaths

A drug used to treat rare autoimmune diseases has been recalled in Ireland following deaths reported in Japan. Tavneos, utilized for adults with severe autoimmune conditions causing blood vessel inflammation, was deemed to have its benefits no longer outweighing the risks after the European Medicines Agency warned in June. The European Commission later endorsed this recommendation.

Distribution in Ireland ceased on August 11, with the Health Products Regulatory Authority initiating a recall of remaining stock. The drug, manufactured by US biotech firm Amgen and sold by various pharmaceutical partners worldwide, was linked to 20 deaths in Japan since 2022, according to Kissei Pharmaceutical, which sells Tavneos in Japan.

Despite some deaths lacking a causal link to the medicine, the company had already alerted doctors to the risk of severe liver dysfunction. Both Amgen and Kissei argued that not all deaths could be attributed to the drug. The HPRA had previously authorized Tavneos for treating around 60 patients in Ireland with rare blood vessel diseases.

The authority stated that only specialists managed these treatments, and some had already decided to withdraw patients from the drug. Despite HPRA's recommendation, patients on Tavneos should continue treatment under medical guidance.