Adverse events attributed to traditional Korean medical practices: 1999-2010.
OBJECTIVE
To investigate adverse events attributed to traditional medical treatments in the Republic of Korea.


METHODS
Adverse events recorded in the Republic of Korea between 1999 and 2010 - by the Food and Drug Administration, the Consumer Agency or the Association of Traditional Korean Medicine - were reviewed. Records of adverse events attributed to the use of traditional medical practices, including reports of medicinal accidents and consumers' complaints, were investigated.


RESULTS
Overall, 9624 records of adverse events attributed to traditional medical practices - including 522 linked to herbal treatments - were identified. Liver problems were the most frequently reported adverse events. Only eight of the adverse events were recorded by the pharmacovigilance system run by the Food and Drug Administration. Of the 9624 events, 1389 - mostly infections, cases of pneumothorax and burns - were linked to physical therapy (n = 285) or acupuncture/moxibustion (n = 1104).


CONCLUSIONS
In the Republic of Korea, traditional medical practices often appear to have adverse effects, yet almost all of the adverse events attributed to such practices between 1999 and 2010 were missed by the national pharmacovigilance system. The Consumer Agency and the Association of Traditional Korean Medicine should be included in the national pharmacovigilance system.
Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Republic of Korea.
Hyeun-Kyoo
HK
Shin
Soo-Jin
SJ
Jeong
Myeong Soo
MS
Lee
Edzard
E
Ernst
D016208:Databases, Factual; D006801:Humans; D007049:Iatrogenic Disease / Q000453:epidemiology*; D055670:Medicine, Korean Traditional; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D060735:Pharmacovigilance; D056910:Republic of Korea / Q000453:epidemiology