Kissei tells doctors in Japan to stop starting new patients on Tavneos after reported deaths and liver injury cases
The Facts
- Kissei Pharmaceutical said 20 fatal cases have been reported in Japan among patients who took Tavneos.
- Kissei told healthcare professionals to stop prescribing Tavneos to new patients in Japan and to reassess treatment for current patients because of severe liver dysfunction risk.
- Kissei said Tavneos has been used by about 8,500 patients in Japan since its launch there in June 2022.
- Postmarketing reports in Japan included 22 cases of vanishing bile duct syndrome among Tavneos users, and 13 of those cases were fatal.
- Tavneos is used in Japan to treat ANCA-associated vasculitis, including microscopic polyangiitis and granulomatosis with polyangiitis.
- Kissei and Amgen said not all of the reported deaths have been confirmed as caused by Tavneos.
- The reports in Japan come after the U.S. FDA warned in March about severe liver injury in patients taking Tavneos and later proposed withdrawing the drug's U.S. approval.
How left and right are reading this
- Both agree
- Reported fatal cases, severe liver dysfunction warnings, and fatal postmarketing reports in Japan are serious enough to justify stopping Tavneos for new patients and reassessing current treatment, even as causation for every death remains unconfirmed.
- They split on
- Less a disagreement than a question of emphasis: patient safety requiring swift action to keep a risky drug off the market, versus evidentiary caution about not treating every reported death as confirmed to have been caused by Tavneos.
Analytical frames for this storyTap to explore
Context
What is Tavneos used for?
Tavneos is approved to treat ANCA-associated vasculitis, including microscopic polyangiitis and granulomatosis with polyangiitis, rare autoimmune diseases that inflame blood vessels AsiaOne,BERNAMA,Kyodo News+.
What action has Kissei taken in Japan?
Kissei sent a notice to healthcare professionals telling them not to start new patients on Tavneos and to evaluate whether current patients should remain on treatment because of the risk of severe liver dysfunction WSJ,Straits Times,Orange Actualités.
Is it confirmed that Tavneos caused all 20 deaths?
No. Multiple reports say Kissei and Amgen stated that a causal link has not been established for all of the reported deaths, even as the companies disclosed the cases and warned about liver-related risks Straits Times,Witness,AsiaOne.
View all 27 sources
Independent coverage (27)
WitnessJapan pharmaceutical firm warns against rare diseases drug a...
Orange ActualitésJapon: un groupe pharmaceutique alerte contre un médicament ...
DT NewsJapan pharma company warns against rare disease drug after 2...
L'essentielUn médicament visé par une alerte après le décès de 20 patie...
Le MatinSanté: Un médicament visé par une alerte majeure après plusi...
Senenews - Actualité Politique, Économie, Sport au SénégalLe médicament Tavneos fait plusieurs décès, le Japon lance l...
La Libre.beJapon: un groupe pharmaceutique alerte contre un médicament ...
The Straits TimesJapan pharmaceutical firm warns against rare diseases drug a...
TV5MONDEJapon: un groupe pharmaceutique alerte contre un médicament ...
Mail OnlineJapan pharmaceutical firm warns against rare diseases drug a...
Пятый канал - Главные новости России и мира сегодняДвадцать человек погибли в Японии от препарата от васкулита
Free Malaysia TodayJapanese drugmaker urges doctors not to use Tavneos for new ...
BERNAMAJapan Drugmaker Urges Doctors Not To Use Tavneos For New Pat...
Kyodo News+Japan drugmaker urges doctors not to use Tavneos for new pat...
НОВОСТИ Mail.RuВ Японии около 20 пациентов погибли от лечения препаратом от...
���.Ru // �������, �����, �������� ���������� ���, ������-������� ���, ��������� �������Около двух десятков пациентов умерли после приема лекарства ...
vesti.ruПрепарат от васкулита унес жизни около 20 пациентов в Японии...
НОВОСТИ Mail.RuВ Японии 20 человек погибли при лечении от васкулита, все он...
kp.ruВ Японии 20 человек погибли при лечении от васкулита, все он...
Московский КомсомолецВ Японии 20 человек скончались после приема лекарственного п...
Свободная ПрессаВ Японии погибло 20 пациентов, принимавших подозрительный пр...
AsiaOneAsiaOne
НОВОСТИ Mail.RuВ Японии при приеме препарата от васкулита погибли около 20 ...
РИА НовостиВ Японии при приеме препарата от васкулита погибли около 20 ...
Bloomberg BusinessAmgen's Tavneos Discouraged by Japanese Partner After Deaths
Investing.com IndiaAmgen stock falls after Kissei warns on Tavneos liver risks ...
The Wall Street Journal20 People in Japan Died After Taking Amgen Drug
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