Sunday, October 26, 2014

3 die after being administered SOVRIAD™ (simeprevir sodium) Hepatitis C drug

3 die after being administered hepatitis C drug

The health ministry said Friday three people have died after taking the hepatitis C drug Sovriad, and it has ordered the distributor to revise the drug packaging to say usage should stop when indicated by a patient blood test.

The ministry also ordered the maker and distributor, Janssen Pharmaceutical K.K., to notify doctors and hospitals in writing of the change.

The package insert already warns of possible deterioration of liver function from use of the drug, known generically as Simeprevir Sodium. The ministry directed the packaging also say usage should be discontinued if a blood test indicates certain abnormalities.

According to the Ministry of Health, Labor and Welfare, taking the drug will increase "bilirubin" by decomposing hemoglobin in the blood and may aggravate dysfunction of the liver and kidney.

Three patients in their 40s to 60s who were taking the drug died in connection with such symptoms, it said.

Since the drug was put on sale last December, about 19,000 people in Japan had used it by the end of September.

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