Rare disease drug recalled in Ireland after Japan deaths

A drug used to treat rare autoimmune diseases has been pulled from shelves in Ireland after it was linked to 20 deaths in Japan.

Tavneos is used to treat adults with severe and rare autoimmune diseases which cause inflammation of the blood vessels.

In June 2026, the European Medicines Agency warned that the benefits of the drug are "no longer proven to outweigh its risks".

It reassessed the data and recommended in July that the drug be stripped of its market authorisation.

The European Commission endorsed that recommendation earlier this month.

In Ireland, the drug stopped being distributed from wholesalers on 11 August and the recall of any remaining stock at wholesale level was requested by the Health Products Regulatory Authority (HPRA) today.

Tavneos is made by the US biotech firm Amgen and is sold by different partner pharmaceutical companies around the world.

Kissei Pharmaceutical, which sells the drug in Japan, said in May that 20 deaths had been reported among people using it since 2022.

The company warned doctors of "the risk of severe liver dysfunction" and asked them to stop prescribing it.

Both Kissei and Amgen said the deaths included cases for which no causal link to the medicine could be determined.

The warning raised doubts about the rigour of the study that was submitted to various regulatory authorities to determine whether it should be authorised for sale.

The HPRA said Tavneos was previously authorised for use in Ireland in adults with severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are rare inflammatory diseases affecting blood vessels.

The authority said before the European Medicines Agency's recommendation, around 60 people were treated with Tavneos.

The HPRA said the drug was only prescribed by consultants with "specialist experience in management of these conditions", adding that some had already made the decision to take patients off this drug.

It said patients currently taking the drug should not stop treatment without first consulting with their doctors.

France's medicine watchdog yesterday announced that Tavneos would be pulled from the country’s shelves.

In the United States, the Food and Drug Administration offered Amgen the option of voluntarily withdrawing Tavneos from shelves.

But the company refused, so a procedure is underway to determine whether they will be forced to pull the drug.

Additional reporting: AFP