Popular drug Tavneos under suspicion: 20 deaths in Japan

IN Japan reported 20 deaths after the appointment Tavneos. Regulators are checking the risk of severe liver damage.

Around the drug Tavneos companies Amgen there was serious concern following reports from Japan: at least 20 patientswho took the drug died due to severe liver dysfunction. However, a direct cause-and-effect relationship with the drug has not been confirmed in all cases.

According to ReutersJapanese company Kissei Pharmaceuticalwhich sells the drug in Japan, recommended that doctors temporarily not prescribe Tavneos new patients and review already started treatment regimens. The reason is the risk of serious liver damage.

According to Kisseipart of the fatal cases to April 27 has been associated with severe liver disease that damages the bile ducts. In the medical literature this condition is known as vanishing bile duct syndrome (vanishing bile duct syndrome). This is a rare but extremely dangerous complication that can lead to severe liver failure.

What is known about the drug

Tavneosactive substance avacopan (avacopan), used to treat severe active ANCA-associated vasculitis. This is a group of rare autoimmune diseases in which small and medium-sized blood vessels become inflamed.

The drug was approved in USA V 2021and in Japan entered the market in 2022. Company Amgen received Tavneos after purchase ChemoCentryx for $3.7 billion. In Japan, according to Reuters, since the launch of the drug, about 8,503 patients. Most severe cases of liver damage, as noted by Kisseiarose during the first three months therapy.

The drug is also available in Greeceas reported separately by Greek media. However, patients should not stop treatment on their own: such decisions should only be made with the attending physician, since the disease for which it is prescribed Tavneosin itself can be difficult and dangerous.

What does the FDA do?

US Food and Drug Administration (FDA) back in March 2026 issued a warning about serious liver damage in patients taking Tavneos. According to the regulator, dozens of cases of drug-induced liver damage, including severe outcomes and deaths, have been identified.

Later FDA proposed to withdraw approval Tavneos in the USA. As he writes Reutersthe regulator cited not only reports of liver damage, but also questions about the evidence of effectiveness and data presented during the drug’s initial approval.

Amgenfor its part, states that it remains confident in the benefit-risk profile of the drug and emphasizes its importance for patients with severe active ANCA-associated vasculitis. The company also indicates that it continues to discuss the situation with regulators.

What is important to patients

The main thing now is not to panic and not make independent decisions. For patients who take Tavneosyou should urgently discuss the situation with your doctor, especially if there are signs of possible liver damage: severe fatigue, yellow skin or eyes, dark urine, pain in the right upper abdomen, nausea, loss of appetite, or unusual itching.

Doctors, according to warnings from regulators and the company Kisseishould closely monitor liver function tests, especially in the first months of therapy, and immediately reconsider treatment if laboratory or clinical signs of impairment appear. This is how medicine reminds us again: even a rare drug for a rare disease can cause a very common problem if control is weak.

Editorial comment

History with Tavneos shows how important post-registration control of drugs is, especially drugs for rare and serious diseases. Clinical trials do not always identify all risks, and real-world data after a drug is marketed may change the safety assessment.

But here we need to be careful with the wording. It cannot be automatically assumed that the drug caused all deaths in Japan: the connection has not been confirmed in all cases. However, when it comes to dozens of severe liver injuries, deaths and a possible recall procedure FDAregulators, doctors and patients should take the signal as seriously as possible. No panic, but also no soothing pharmaceutical fog.

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