<b>Examination of Frequency and Nature of Side Effects Caused by Over-The-Counter Kampo Formulations Based on the Data Published by the Japanese Ministry of Health, Labour and Welfare</b> / 日本東洋医学雑誌

ABSTRACT

The number and the nature of reported side effects caused by over-the-counter Kampo formulations (OKF), as well as their changes over 10 years (fiscal years 2005 through 2014), were investigated using the data published on the website of the Japanese Ministry of Health, Labour and Welfare. The total number of side effects reports regarding OKF was 367 during the period, including 151 reports of liver dysfunction, 54 reports of drug eruption/hypersensitivity, and 51 reports of lung injury. Annual incidence of reported side effects increased nearly threefold over the period, from 16 in 2005 to 43 in 2014. Bofutsushosan was involved in 110 cases, kakkonto in 45 cases, hachimijiogan in 15 cases, and daisaikoto in 14 cases. The number of side effects due to bofutsushosan and kakkonto showed an increasing trend during the period from 2005 to 2014. Bofutsushosan was associated with 65 cases of liver dysfunction and 23 cases of lung injury. Kakkonto was associated with 21 cases of drug eruption/hypersensitivity. Under the current circumstances, severe side effects requiring medical treatments such as liver dysfunction and lung injury are showing a tendency to increase. To improve safety, we recommend tighter control over the sale of OKF, especially bofutsushosan and kakkonto,which accounted for nearly half of all reported side effects.