Rare disease drug recalled in Ireland after deaths in Japan

Irish health authorities recalled the rare autoimmune disease drug Tavneos this week following reports of around 20 deaths in Japan since its 2022 launch, officials said. The deaths were linked to serious liver dysfunction, including vanishing bile duct syndrome, according to safety notices from Kissei Pharmaceutical, which handles Tavneos sales in Japan.

The Health Products Regulatory Authority (HPRA) in Ireland announced a recall of all remaining Tavneos stock at the wholesale level on Aug. 20, 2026, following the European Medicines Agency’s (EMA) conclusion that the drug’s benefits no longer outweighed its risks. The recall came after the EMA’s June 2026 reassessment and the European Commission’s endorsement of the recommendation to revoke Tavneos’ marketing authorization across the European Union in August 2026, officials said. Tavneos had been authorized in Ireland for adults with severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), both rare inflammatory diseases of small blood vessels, according to HPRA records.

Kissei issued a safety notice on May 15, 2026, reporting about 20 deaths linked to serious liver dysfunction, including cases of vanishing bile duct syndrome (VBS), a severe form of drug-induced liver injury (DILI).

The decision followed safety concerns arising from reports in Japan, where Tavneos was launched in 2022 and has since been used to treat approximately 8,500 patients, according to Kissei Pharmaceutical, which manages the drug’s sales and distribution in Japan. The company warned of the risk of severe liver dysfunction and advised physicians to stop initiating new Tavneos treatments and to closely monitor liver function in ongoing patients, discontinuing the drug if abnormalities appeared.

Alongside the fatalities, Kissei reported at least 22 patients developing potentially fatal liver injuries while on Tavneos. However, both Kissei and Amgen, the drug’s international marketer, stated that a direct causal relationship between Tavneos and all reported deaths has not been definitively established, according to company statements and safety notices. Despite this, the severity and number of liver-related adverse events prompted regulators to take precautionary measures.

Following the Japanese safety alerts, U.S. regulators reportedly requested that Amgen voluntarily withdraw Tavneos from the American market, although the majority of deaths and liver injury cases have been documented in Japan, media reports indicated. In Europe, the EMA’s review incorporated the Japanese safety data and broader pharmacovigilance assessments, leading to its conclusion that Tavneos’ benefit-risk balance was no longer favorable. The European Commission subsequently endorsed the EMA’s recommendation to revoke the marketing authorization, effectively removing Tavneos from the EU market.

Ireland ceased distribution of Tavneos from wholesalers on Aug. 11, 2026, ahead of the HPRA’s formal recall request. France’s medicines safety agency also announced on Aug. 19, 2026, that Tavneos would be withdrawn from the French market, citing the same link to approximately 20 deaths in Japan. French authorities emphasized the drug’s use in treating severe active ANCA-associated vasculitis, a group of rare autoimmune diseases similar to those targeted in Ireland and elsewhere in Europe.

The recalls and market withdrawals across the EU affect patients with rare autoimmune diseases who relied on Tavneos for treatment. Health authorities in Ireland and other countries are expected to provide guidance to clinicians on alternative therapies and patient management following the drug’s removal from the market.

Kissei and regulatory agencies continue to stress the importance of regular liver function monitoring in patients who have been treated with Tavneos and recommend immediate discontinuation if liver abnormalities are detected. While new prescriptions of Tavneos were temporarily discouraged in Japan following the initial safety notice, Japanese guidance later allowed treatment to resume under stricter liver safety warnings. In contrast, European regulators opted for market withdrawal rather than restricted use, citing the overall negative benefit-risk profile.

Tavneos is indicated for severe active granulomatosis with polyangiitis and microscopic polyangiitis, both forms of ANCA-associated vasculitis characterized by inflammation of small blood vessels. The drug is marketed internationally by Amgen, with Kissei Pharmaceutical responsible for sales in Japan. The reported cluster of liver-related deaths and injuries in Japan since Tavneos’ 2022 launch prompted the global regulatory response culminating in the recent recalls and authorization revocations.