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Nihon Pharma Failed To Inform Patients About Factor IX Administration

This article was originally published in PharmAsia News

Executive Summary

Nihon Pharmaceutical, manufacturer of Factor IX product PPSB-Nichiyaku, announced that it withheld information on two patients who were administered the product and later affected by hepatitis C. The company received the information from a medical facility around 1979 and failed to notify the patients. Earlier this month, after it received an order from Japan's Ministry of Health, Labor and Welfare, Nippon Pharma started looking for the two patients; however, since the medical facility did not keep their records, the specific persons have yet to be notified. Nippon Pharma has expressed regret about the incident and called for concerned parties to step forward. Nippon Pharma is the second pharmaceutical company admitting to have kept such information secret, after Mitsubishi Tanabe acknowledged it failed to notify patients regarding Fibrinogen. (Click here for more-Japanese language
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