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Japan drugmaker urges doctors not to prescribe Tavneos to kidney patients after reported fatal cases

By The South Asia Times

TOKYO - Japanese pharmaceutical company Kissei Pharmaceutical Co. has urged doctors to avoid prescribing the kidney disease drug Tavneos to new patients following reports of multiple deaths potentially linked to its use in Japan, according to Kyodo News.

The company said the precautionary notice was issued to healthcare professionals after around 20 deaths were reported in cases where the drug was suspected to have been involved. Tavneos has been used in Japan since June 2022 to treat rare inflammatory kidney disorders, including microscopic polyangiitis and granulomatosis with polyangiitis, affecting roughly 8,500 patients.

The drug is exclusively marketed in Japan by Kissei Pharmaceutical under license from its original developer, Amgen.

Kissei said it is advising physicians to carefully evaluate whether to continue treatment in existing patients while stopping short of a full suspension of use, as regulatory approval for Tavneos remains in place in Japan.

The warning follows earlier concerns raised by the U.S. Food and Drug Administration, which in March flagged risks of severe liver injury linked to the drug and later proposed withdrawal of its approval in the United States after allegations regarding trial data provided by the developer.

According to company data, Japan has reported 22 cases of vanishing bile duct syndrome among patients taking Tavneos, including 13 deaths.

Kissei said it will continue monitoring safety information in coordination with health authorities as scrutiny over the drug intensifies.

Japan drugmaker urges doctors not to prescribe Tavneos to kidney patients after reported fatal cases

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