Kissei Ordered to Warn over Vasculitis Drug after Fatalities

Tokyo, May 21 (Jiji Press)–Japan’s health ministry on Thursday ordered Kissei Pharmaceutical Co. to add a warning to the package insert of Tavneos, a drug for vasculitis, or blood vessel inflammation, after the deaths of 20 patients who took the medicine. To alert medical staff, the Japanese drugmaker was ordered to stipulate the fact that patients have died after developing liver dysfunction following the use of the prescription drug. Tavneos, developed by a U.S. drugmaker, was approved by the ministry and launched in Japan in June 2022, with its package insert citing liver dysfunction as a possible serious side effect. The drug is estimated to have been administered to 12,000 to 13,000 patients in Japan. All 20 dead patients developed liver dysfunction, and 210 similar side effect reports have been made, including suspected cases. The ministry has already warned against newly administering the drug to patients. The additional warning on the package insert says that “serious liver dysfunction, such as vanishing bile duct syndrome, may occur, and there have been reported cases of death.” The warning also advises medical staff to conduct regular liver function tests on patients during the use of the drug and take appropriate measures, such as stopping its use, if liver function abnormality appears. As important precautions, the warning says that liver dysfunction often occurs within the first three months of administration. Also, the ministry issued safety information to medical institutions through Kissei Pharmaceutical that the 20 patients were men and women in their 60s to 90s and that vanishing bile duct syndrome was observed in 13 of them. Other side effects, including acute liver failure and liver function abnormality, were also observed in patients. Since vasculitis itself is severe disease, the ministry is investigating a possible relationship with the deaths. The ministry urged patients taking the drug to visit a medical institution promptly if they have discoloration of urine or skin or stomachache. END [Copyright The Jiji Press, Ltd.]