「PMDA 医薬品副作用データベース」を利用した漢方製剤の 副作用の解析

Abstract

Objective: Recently, since usage of the kampo-medicines has changed from conventional usage, it is possible that the tendency of adverse reaction also changes. Pharmaceuticals and Medical Devices Agency (PMDA) discloses information reported by Pharmaceuticals and Medical Devices Safety Information Reporting System. In this study, we analyzed adverse drug events of kampo-medicines using Japanese Adverse Drug Event Report (JADER) database of PMDA. We also investigated what adverse drug events are likely to be occurred by kampo-medicines and what kampo-medicine is likely to cause a particular adverse drug event. Methods: We focused on reports referring to suspected drugs for kampo-medicines from JADER database of PMDA for about nine years from April 2004 to February 2013. We analyzed kampo-medicines, organs, and adverse drug events based on the number of reports. Results and Conclusion: We found 1,958 reports on adverse drug events for kampo-medicines. The largest number of reports for kampo-medicines was on Shakuyakukanzoto, followed in order by Bofutsushosan, Saireito and Yokukansan. The breakdown of each organ of adverse drug events reported was 34% for hepatobiliary system disorders, followed in order by 26% for respiratory, thoracic and mediastinal disorders, and 9% for metabolism and nutrition disorders. A total of the above adverse drug events accounts for 70% of all adverse drug events. The largest number of adverse drug events reported was 406 cases for interstitial lung disease, followed in order by 294 cases for liver disorder, 260 cases for hepatic dysfunction, 165 cases for hypokalemia, and 102 cases for pseudoaldosteronism. There are many reports about pseudoaldosteronism of Yokukansan regardless of containing only 1.5 g ricorice per day. As for cardiac disorders of Yokukansan, we need to pay attention to information in the future.