TOKYO, May 18 (News On Japan) –
Japan’s Health, Labour and Welfare Ministry said on May 18th it had instructed Kissei Pharmaceutical to report the facts surrounding the deaths of 20 patients who had taken a treatment drug for vasculitis.
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The drug, called Tavneos, is used to treat vasculitis, a rare autoimmune disease that causes inflammation of blood vessels. The medicine was developed by a U.S. company and is sold in Japan by Nagano-based Kissei Pharmaceutical.
According to the company, cases of severe liver dysfunction were reported after patients took the drug, with 20 deaths subsequently recorded.
An estimated 8,500 people in Japan have used the medication so far. Kissei Pharmaceutical has urged medical institutions to refrain from administering the drug to new patients, while advising doctors treating current patients to carefully assess whether treatment should continue after fully explaining the risks and possible alternative therapies.
Health minister Ueno said the ministry had ordered the company to submit a detailed report on the matter.
Meanwhile, in the United States, a proposal has been made to withdraw approval of the drug after allegations that the approval application contained statements inconsistent with the facts. Ueno said authorities in Japan would continue to examine questions surrounding the data while monitoring developments in the United States and Europe.
Source: FNN
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