Drug Safety

, Volume 23, Issue 5, pp 351–362 | Cite as

Chinese Proprietary Medicine in Singapore

Regulatory Control of Toxic Heavy Metals and Undeclared Drugs
Leading Article

Abstract

Traditional Chinese medicine (TCM) is gaining popularity as a form of complementary and alternative medicine. Reports of efficacy of TCM are increasing in numbers. TCM includes both crude Chinese medicinal materials (plants, animal parts and minerals) and Chinese proprietary medicine (CPM) [final dosage forms]. Despite the belief that CPM and herbal remedies are of natural origin, unlike Western medicine, and are hence safe and without many adverse effects, there have been numerous reports of adverse effects associated with herbal remedies. Factors affecting the safety of herbal medicines include intrinsic toxicity, adulteration, substitution, contamination, misidentification, lack of standardisation, incorrect preparation and/or dosage and inappropriate labelling and/or advertising. Hence, new regulations on the control of CPM were enforced in Singapore with effect from 1 September 1999. These include licensing and labelling requirements, as well as control of microbial contamination. This article also reviews reports of excessive toxic heavy metals and undeclared drugs in CPM in Singapore between 1990 and 1997. The names, uses, toxic heavy metal or drug detected and the year of detection are tabulated. Information on the brand or manufacturer’s name are provided whenever available. The public and healthcare professionals should be better informed of the basic concept of TCM and its usefulness, as well as the potential adverse effects associated with its use. Greater control over the safety and quality of CPM could be achieved through good manufacturing practice, regulatory control, research, education, reporting usage of Chinese medicine (as in drug history) as well as reporting of adverse events.

References

  1. 1.
    Anonymous. Program profile: international liaison brings global vision to OAM. Complementary and Alternative Medicine at the NIH 1996; 3:3Google Scholar
  2. 2.
    Eisenberg DM, Ronald CK, Forster C, et al. Unconventional medicine in the United States: prevalence, costs, and patterns of use. N Engl J Med 1993; 328: 246–52CrossRefPubMedGoogle Scholar
  3. 3.
    MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569–72CrossRefPubMedGoogle Scholar
  4. 4.
    Zhu YP. Chinese materia medica: chemistry, pharmacology and applications. Amsterdam: Harwood Academic Publishers, 1998Google Scholar
  5. 5.
    Fok TF, Lau SP, Hui CW. Chinese herbs in pregnancy and neonatal jaundice. Hong Kong J Paediatr 1985; 2: 138–44Google Scholar
  6. 6.
    Chan YK. The prevalence, use and harmful potential of some chinese herbal medicines in babies and children. Vet Hum Toxicol 1994; 36 (3): 238–40PubMedGoogle Scholar
  7. 7.
    Traditional Chinese medicine: a report by the Committee on Traditional Chinese Medicine. Singapore: Ministry of Health, 1995Google Scholar
  8. 8.
    Huxtable RJ. The harmful potential of herbal and other plant products. Drug Saf 1990; 5 Suppl. 1: 126–36CrossRefPubMedGoogle Scholar
  9. 9.
    Drew AK, Myers SP. Safety issues in herbal medicine: implications for the health professions. Med J Aust 1997; 166 (19): 538–41PubMedGoogle Scholar
  10. 10.
    Chan YK, Critchley JAJH. Usage and adverse effects of Chinese herbal medicines. Hum Exp Toxicol 1996; 15: 5–12CrossRefPubMedGoogle Scholar
  11. 11.
    Dickens P, Tai YT, But PPH, et al. Fatal accidental aconitine poisoning following ingestion of Chinese herbal medicine: a report of 2 cases. Forensic Sci Int 1994; 67: 55–8CrossRefPubMedGoogle Scholar
  12. 12.
    Vanherweghem JL, Depierreux M, Tielemans C et al. Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet 1993; 341: 387–91CrossRefPubMedGoogle Scholar
  13. 13.
    Vanhaelen M, Vanhaelen-Fastre R, But P, et al. Identification of aristolochic acid in Chinese herbs [letter]. Lancet 1994; 343: 174CrossRefPubMedGoogle Scholar
  14. 14.
    Shaw D, Murray V, Volans G. Adverse effects of herbal remedies and OTC medicines. Br J Clin Pharmacol 1999; 47 (2): 227–8PubMedGoogle Scholar
  15. 15.
    Shaw D, Leon C, Kolev S, et al. Traditional remedies and food supplements: a 5-year toxicological study 1991-1995. Drug Saf 1997; 17 (5): 342–56CrossRefPubMedGoogle Scholar
  16. 16.
    De Smet PAGM. Overview of herbal quality control. Drug Inf J 1999; 33: 717–24CrossRefGoogle Scholar
  17. 17.
    De Smet PAGM. Health risks of herbal remedies. Drug Saf 1995; 13 (2): 81–93CrossRefPubMedGoogle Scholar
  18. 18.
    De Smet PAGM, editor. Adverse effects of herbal drugs. Vol. I. Berlin: Springer Verlag, 1992Google Scholar
  19. 19.
    De Smet PAGM, editor. Adverse effects of herbal drugs. Vol II. Berlin: Springer Verlag, 1993Google Scholar
  20. 20.
    De Smet PAGM, editor. Adverse effects of herbal drugs. Vol III. Berlin: Springer Verlag, 1997Google Scholar
  21. 21.
    Forster S, Tyler VE. Tyler’s honest herbal: a sensible guide to the use of herbs and related remedies. 4th ed. New York (NY): Haworth Press, 1999Google Scholar
  22. 22.
    Newall CA, Anderson LA, Phillipson JD. Herbal remedies: a guide for healthcare professionals. London: The Pharmaceutical Press, 1996Google Scholar
  23. 23.
    The Chinese Pharmacopoeia Commission of the Ministry of Public Health. Pharmacopoeia of the People’s Republic of China, 1995 edition. Vol. 1. Guangdong: Guangdong Technology Publisher and Chemical Industries Publisher, 1995Google Scholar
  24. 24.
    Hikino H, Yamada C, Nakamura K, et al. Change of alkaloid composition and acute toxicity of Aconitum roots during processing. Yakugaku Zasshi 1977; 97: 359–66PubMedGoogle Scholar
  25. 25.
    Du S, Cao F, Lei S. A survey of adverse effects of Chinese herbal drugs in China, 1915-1990. Chung Kuo Chung Yao Tsa Chih 1992; 17: 435–8PubMedGoogle Scholar
  26. 26.
    Yuan H, Tan D. A review of the literature of the adverse effects of Chinese herbal drugs as published in major medical and pharmacology journals in China in 1990. Chung Kuo Chung Yao Tsa Chih 1991; 16: 628–34PubMedGoogle Scholar
  27. 27.
    The statutes of the Republic of Singapore: medicines act (chapter 176), revised edition 1990. Singapore: The Government Printer, Ministry of HealthGoogle Scholar
  28. 28.
    Jiang Su Xin Yi Xue Yuan. Zhong Yao Da Ci Dian (A dictionary of Chinese pharmacy). Shanghai: Shang Hai Ke Xue Ji Shu ChuBan She, 1977Google Scholar
  29. 29.
    Li Shi Zhen (1518-1593). Ben Cao Gang Mu (The Chinese herbal medicine materia medica). 1596Google Scholar
  30. 30.
    The statutes of the Republic of Singapore: poisons act (chapter 234), revised edition 1999. Singapore: The Government Printer, Ministry of HealthGoogle Scholar
  31. 31.
    The statutes of the Republic of Singapore: medicines (advertisement and sale) act (chapter 177), revised edition 1985. Singapore: The Government Printer, Ministry of HealthGoogle Scholar
  32. 32.
    The statutes of the Republic of Singapore: sale of drugs act (chapter 282), revised edition 1985. Singapore: The Government Printer, Ministry of HealthGoogle Scholar
  33. 33.
    Ennever FK. Metals. In: Hayes WA, editor. Principles and methods of toxicology. 3rd ed. New York (NY): Raven Press, 1994: 417–46Google Scholar
  34. 34.
    Olson KR, editor. Poisoning and drug overdose. 3rd ed. Stanford (CT): Appleton & Lange, 1999Google Scholar
  35. 35.
    Dukes MNG, editor. Meyler’s side effects of drugs: an encyclopedia of adverse reactions and interactions. 13th ed. Amsterdam: Elsevier Science, 1996Google Scholar
  36. 36.
    Klaassen CD, Amdur MO, Doull J, editors. Casarett and Doull’s toxicology: the basic science of poisons. 5th ed. New York (NY): McGraw-Hill, 1996Google Scholar
  37. 37.
    Kang YE, Oransky SH. Chinese patent medicine as a potential source of mercury poisoning. Vet Hum Toxicol 1992; 34 (3): 235–8Google Scholar
  38. 38.
    Tay CH, Seah CS. Arsenic poisoning from anti-asthmatic herbal preparations. Med J Aust 1975; 2: 424–8PubMedGoogle Scholar
  39. 39.
    Yeung HC. Handbook of Chinese herbs and formulas. Vol. II. Los Angeles (CA): Institute of Chinese Medicine, 1985Google Scholar
  40. 40.
    Yu ECL, Yeung CY. Lead encephalopathy due to herbal medicine. Chin Med J 1987; 100: 915PubMedGoogle Scholar
  41. 41.
    Chia BL, Leng CK, Hsii FP, et al. Lead poisoning from contaminated opium. BMJ 1973; 1: 354CrossRefPubMedGoogle Scholar
  42. 42.
    Schilcher H. Contamination of natural products with pesticides and heavy metals. In: Breimer DD, Speiser P, editors. Topics in pharmaceutical sciences. Amsterdam: Elsevier Science, 1983: 417–23Google Scholar
  43. 43.
    Woolf GM, Petrovic LM, Rojter SE, et al. Acute hepatitis associated with the Chinese herbal product Jin Bu Huan. Ann Intern Med 1994; 121 (10): 729–35PubMedGoogle Scholar
  44. 44.
    Ministry warning on Jin Bu Huan pills. The Straits Times. Singapore: Singapore Press Holdings: 8 Mar 1995Google Scholar
  45. 45.
    Tung Shueh Wan herbal product has poinonous substances; Health Ministry. The Straits Times. Singapore: Singapore Press Holdings: 1 Nov 1992Google Scholar
  46. 46.
    Abt AB, Oh JY, Huntingdon RA, et al. Chinese herbal medicine induced acute renal failure. Arch Intern Med 1995; 155 (2): 211–2CrossRefPubMedGoogle Scholar
  47. 47.
    Illegal sale of medicinal [press release]. Singapore: Ministry of Health, 1997 NovGoogle Scholar
  48. 48.
    Tang W, Eisenbrand G. Chinese drugs of plant origin. Berlin: Springer Verlag, 1992CrossRefGoogle Scholar
  49. 49.
    Yeung CY, Lee FT, Wong HN. Effects of a popular Chinese herb on neonatal bilirubin protein binding. Biol Neonate 1990; 58: 98–103CrossRefPubMedGoogle Scholar
  50. 50.
    International Agranulocytosis and Aplastic Anemia Study. Risks of agranulocytosis and aplastic anemia: a first report of their relation to drug use with special reference to analgesics. JAMA 1986; 256: 1749Google Scholar
  51. 51.
    Two die after taking ‘wonder’ pills for diabetes: made-in-China drug has been banned in Singapore since 1977. The Straits Times. Singapore: Singapore Press Holdings: 24 Jul 1990Google Scholar
  52. 52.
    Huang WF, Wen KC, Hsiao ML. Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan. J Clin Pharmacol 1997; 37: 344–50PubMedGoogle Scholar
  53. 53.
    Liu SY, Woo SO, Holmes MJ, et al. LC and LC-MS-MS analyses of undeclared codeine in antiasthmatic Chinese proprietary medicine. J Pharm Biomed Anal 2000; 22 (3): 481–6CrossRefPubMedGoogle Scholar
  54. 54.
    Ko RJ. Causes, epidemiology and clinical evaluation of suspected herbal poisoning. Clin Toxicol 1999; 37 (6): 697–708CrossRefGoogle Scholar
  55. 55.
    Tomlinson B, Chan TY, Chan JC, et al. Toxicity of complementary therapies; an eastern perspective. J Clin Pharmacol 2000; 40 (5): 451–6CrossRefPubMedGoogle Scholar
  56. 56.
    Boullata JI, Nace AM. Safety issues with herbal medicine. Pharmacotherapy 2000; 20 (3): 257–69CrossRefPubMedGoogle Scholar
  57. 57.
    Marrone CM. Safety issues with herbal products. Ann Pharmacother 1999; 33 (12): 1359–69CrossRefPubMedGoogle Scholar
  58. 58.
    Miller LG, Hume A, Harris IM, et al. White paper on herbal products. Pharmacotherapy 2000; 20 (7): 877–91CrossRefPubMedGoogle Scholar

Copyright information

© Adis International Limited 2000

Authors and Affiliations

  1. 1.Department of Pharmacy, Faculty of ScienceNational University of SingaporeSingaporeSingapore
  2. 2.Department of Scientific ServicesInstitute of Science and Forensic Medicine, Ministry of HealthSingapore

Personalised recommendations