Yonsei Med J.  2014 Sep;55(5):1177-1186. 10.3349/ymj.2014.55.5.1177.

Adverse Events Associated with Metal Contamination of Traditional Chinese Medicines in Korea: A Clinical Review

• Kim H
• Hughes PJ
• Hawes EM

• KMID: 1799479
• DOI: http://doi.org/10.3349/ymj.2014.55.5.1177

Abstract

This study was performed to review studies carried out in Korea reporting toxic reactions to traditional Chinese medicines (TCMs) as a result of heavy metal contamination. PubMed (1966-August 2013) and International Pharmaceutical Abstracts (1965-August 2013) were searched using the medical subject heading terms of "Medicine, Chinese Traditional," "Medicine, Korean Traditional," "Medicine, Traditional," "Metals, Heavy," and "Drug Contamination". For Korean literature, Korea Med (http://www.koreamed.org), the Korean Medical Database (http://kmbase.medric.or.kr), National Discovery for Science Leaders (www.ndsl.kr), Research Information Sharing Service (http://www.riss.kr), and Google Scholar were searched using the terms "Chinese medicine," "Korean medicine," "herbal medicine," and "metallic contamination" in Korean. Bibliographies of case reports and case series, identified using secondary resources, were also utilized. Only literature describing cases or studies performed in Korea were included. Case reports identified clear issues with heavy metal, particularly lead, contamination of TCMs utilized in Korea. No international standardization guidelines for processing, manufacturing and marketing of herbal products exist. Unacceptably high levels of toxic metals can be present in TCM preparations. Health care providers and patients should be educated on the potential risks associated with TCMs. International advocacy for stricter standardization procedures for production of TCMs is warranted.

Keyword

Medicine; Korean traditional; medicine; chinese traditional; metals; heavy

MeSH Terms

*Drug Contamination
Drugs, Chinese Herbal/*adverse effects/chemistry
Humans
Medicine, Chinese Traditional
Medicine, Korean Traditional
Metals, Heavy/*poisoning
*Poisoning
Republic of Korea
Risk Assessment
Drugs, Chinese Herbal
Metals, Heavy

Reference

1. Xu J, Yang Y. Traditional Chinese medicine in the Chinese health care system. Health Policy. 2009; 90:133–139.

2. Liu CX. Development of Chinese medicine based on pharmacology and therapeutics. J Ethnopharmacol. 1987; 19:119–123.

3. Koh HL, Woo SO. Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugs. Drug Saf. 2000; 23:351–362.

4. The regional strategy for traditional medicine in the Western Pacific (2011-2020). Manila: World Health Organization, Regional Office for the Western Pacific;2002. accessed on 2013 December 20. Available at: http://www.wpro.who.int/publications/2012/regionalstrategyfortraditionalmedicine_2012.pdf.

5. Ernst E. Toxic heavy metals and undeclared drugs in Asian herbal medicines. Trends Pharmacol Sci. 2002; 23:136–139.

6. Tomlinson B, Chan TY, Chan JC, Critchley JA, But PP. Toxicity of complementary therapies: an eastern perspective. J Clin Pharmacol. 2000; 40:451–456.

7. Winslow LC, Kroll DJ. Herbs as medicines. Arch Intern Med. 1998; 158:2192–2199.

8. Shin HK, Jeong SJ, Lee MS, Ernst E. Adverse events attributed to traditional Korean medical practices: 1999-2010. Bull World Health Organ. 2013; 91:569–575.

9. Kim JY, Kim JH, Kim HW, Roh JH, Lee KH, Cheon BC, et al. A review of lead poisoning cases reported for recent 30 years in Korea. Korean J Med. 2004; 66:617–624.

10. Sakai T. Biomarkers of lead exposure. Ind Health. 2000; 38:127–142.

11. Kim YS, Park YG, Shu WJ, Kim MJ, Bae JH, Chi HS. Clinical study on lead poisoning. Korean J Intern Med. 1980; 23:707–713. In Korean.

12. Baek IK, Kim WT, Choi MR, Kwon SO, Yu SI, Shin KC, et al. Acute lead intoxication caused by Chinese Traditional Pills. Korean J Intern Med. 1985; 29:763–770. In Korean.

13. Kim SS, Park SK, Han YB, Han DS, Huh MH. Lead poisoning in Korean adults caused by herbal medicine-report of 4 cares. Korean J Hematol. 1989; 24:203–209.

14. Kim DS, Lim HS, Yang CH. Case report of a lead poisoning by home-made herb pills. Korean J Rural Med. 2001; 26:57–64.

15. Choi SH, Park EY, Shim JY, Kim DS, Shim JW, Jung HL, et al. Two cases of lead poisoning due to herb medicinal pills. Korean J Pediatr. 2005; 48:1009–1015.

16. Oh SW, Lee HJ, Chae HJ, Lee SK, Moon JD, Cho D. A case of lead poisoning after ingestion of herb pills. Korean J Occup Environ Med. 2007; 19:231–237.

17. Park HS, Kim SY, Cho JH, Moon HW, Yoon SY, Cho YH, et al. A case of sideroblastic anemia caused by lead-containing herbal medication. Korean J Med. 2010; 79:448–452.

18. Kim BJ, Kim SY, Kim GM. A case of multiple SCCs in situ and BCC induced probably by chronic exposure to arsenic-containing pills (Hwan-Yak). Korean J Dermatol. 2009; 47:1071–1073.

19. Lee EY, Shin HS, Jung YS, Chun BK, Rim H. A case of rapidly progressive renal failure induced by cadmium intoxication. Korean J Med. 2010; 78:761–765.

20. Klaassen CD. Heavy metals and heavy metal antagonists. In : Hardman JG, Limbird LE, editors. The Pharmacological Basis of Therapeutics. 10th ed. New York: Macmillan;2001. p. 1851–1875.

21. American Academy of Pediatrics Committee on Drugs. Treatment guidelines for lead exposure in children. Pediatrics. 1995; 96(1 Pt 1):155–160.

22. Wang EE, Mahajan N, Wills B, Leikin J. Successful treatment of potentially fatal heavy metal poisonings. J Emerg Med. 2007; 32:289–294.

23. Brodkin E, Copes R, Mattman A, Kennedy J, Kling R, Yassi A. Lead and mercury exposures: interpretation and action. CMAJ. 2007; 176:59–63.

24. Garvey GJ, Hahn G, Lee RV, Harbison RD. Heavy metal hazards of Asian traditional remedies. Int J Environ Health Res. 2001; 11:63–71.

25. Ernst E. Heavy metals in traditional Indian remedies. Eur J Clin Pharmacol. 2002; 57:891–896.

26. Lynch E, Braithwaite R. A review of the clinical and toxicological aspects of 'traditional' (herbal) medicines adulterated with heavy metals. Expert Opin Drug Saf. 2005; 4:769–778.

27. Harris ES, Cao S, Littlefield BA, Craycroft JA, Scholten R, Kaptchuk T, et al. Heavy metal and pesticide content in commonly prescribed individual raw Chinese Herbal Medicines. Sci Total Environ. 2011; 409:4297–4305.

28. Korean Food and Drug Administration (KFDA) website. accessed on 2013 December 11. Available at: http://www.kfda.go.kr.

29. Food and Drug Administration Office of Compliance Website. Inspections, Compliance, Enforcement, and Criminal Investigations. accessed on 2013 December 11. Available at: http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm.

30. United States Pharmacopeia Advisory Panel on Metal Impurities. accessed on 2013 December 11. Available at: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/key-issues/2009-04-22MetalImpuritiesToxChart.pdf.

31. Homeopathic Pharmacopeia of the United States website. accessed on 2013 December 11. Available at: http://www.hpus.com/overview5.php.

32. Genuis SJ, Schwalfenberg G, Siy AK, Rodushkin I. Toxic element contamination of natural health products and pharmaceutical preparations. PLoS One. 2012; 7:e49676.