A medication used to treat rare autoimmune diseases has been pulled from shelves in Ireland after regulators revisited its safety profile and reports in Japan linked its use to 20 deaths.
The move underscores how quickly the outlook for an approved drug can change when new evidence emerges after it reaches patients.
Here's what to know
Tavneos had been authorized in Ireland for adults with severe active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), two rare diseases involving inflammation of blood vessels. After wholesalers stopped distributing it on Aug. 11, the Health Products Regulatory Authority requested a recall of any remaining stock, according to RTÉ.
European regulators first signaled concern in June, when the European Medicines Agency said the benefits of Tavneos were "no longer proven to outweigh its risks." After reviewing the data again, the agency recommended in July that the medicine lose its market authorization, a move later endorsed by the European Commission.
Amgen, the U.S. biotech company behind Tavneos, sells the drug through partner companies in different markets. In Japan, Kissei Pharmaceutical said in May that 20 deaths had been reported since 2022 among people using the medicine.
That notice told doctors to stop prescribing Tavneos and cited "the risk of severe liver dysfunction." Kissei and Amgen also said some of the deaths had not been confirmed to have been caused by the drug.
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More background
Medicines are not judged only once at approval. Regulators continue reviewing real-world reports, study quality, and new safety signals as more patients begin using them.
Before the European Medicines Agency's recommendation, about 60 people in Ireland had been treated with Tavneos, the HPRA said. The regulator added that the drug was prescribed only by consultants with "specialist experience in management of these conditions," and that some specialists had already chosen to take patients off it.
A withdrawal does not automatically mean every reported harm was definitively caused by the drug, but it does mean regulators saw enough reason for concern to step in.
What's being done?
The response has spread beyond Ireland. Wholesale distribution there was stopped and remaining stock is being recalled, while France's medicine watchdog has said Tavneos will also be removed from sale.
In the United States, the Food and Drug Administration offered Amgen the option of withdrawing Tavneos voluntarily. After the company declined, a process began to determine whether it will be required to pull the drug there.
For patients already taking Tavneos, the HPRA said they should speak with their doctor before stopping. The people prescribed the drug are dealing with severe autoimmune illnesses, and abrupt treatment changes can create new health risks.
Institutional responses may continue to evolve as agencies compare evidence across countries and decide what protections patients need.
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