Adverse events associated with the use of complementary medicine and health supplements: An analysis of reports in the Singapore Pharmacovigilance database from 1998 to 2009

Clinical Toxicology

Volumn 50, Issue 6, 2012, Pages 481-489

  Patel, Dhavalkumar Narendrabhai ^a   Low, Wai Ling ^a   Tan, Libei Liesbet ^b   Tan, Mui Mui Belinda ^b   Zhang, Qian ^b   Low, Min Yong ^b   Chan, Cheng Leng ^b   Koh, Hwee Ling ^a  

^a NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^b HEALTH SCIENCES AUTHORITY   (Singapore)

Author keywords

Adulteration; Adverse events; Hepatotoxicity; Hypoglycemia; Pharmacovigilance

Indexed keywords

CHINESE DRUG; ILLICIT DRUG;

ABDOMINAL PAIN; ACUTE KIDNEY FAILURE; ADOLESCENT; ADRENAL INSUFFICIENCY; ADULT; ALTERNATIVE MEDICINE; ANEMIA; ARTHRALGIA; BLINDNESS; BLOOD CLOTTING DISORDER; BLURRED VISION; CAUSAL ATTRIBUTION; CENTRAL NERVOUS SYSTEM DISEASE; CHILD; CHINESE MEDICINE; COMA; CONFUSION; CUSHING DISEASE; DATA BASE; DEATH; DEMOGRAPHY; DIABETES MELLITUS; DIAPHORESIS; DIET SUPPLEMENTATION; DIZZINESS; DROWSINESS; DRUG FATALITY; DRUG INDICATION; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; DYSPNEA; ENDOCARDITIS; ENDOCRINE DISEASE; EOSINOPHILIA; FEMALE; FEVER; HEART INFARCTION; HEART PALPITATION; HEMOLYSIS; HEPATITIS; HOSPITALIZATION; HUMAN; HYPERMENORRHEA; HYPERTENSION; HYPOGLYCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOTENSION; INFANT; INSOMNIA; JAUNDICE; LETHARGY; LEUKOPENIA; LIVER CELL CARCINOMA; LIVER FAILURE; LIVER TOXICITY; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MENTAL HEALTH; METHEMOGLOBINEMIA; MYALGIA; MYOCARDITIS; MYOPATHY; NAUSEA; NECK PAIN; OLIGOMENORRHEA; OUTCOMES RESEARCH; PAIN; PANCYTOPENIA; POSTMENOPAUSE BLEEDING; PROTHROMBIN TIME; RASH; RESPIRATORY FAILURE; REVIEW; RHABDOMYOLYSIS; SEPTIC SHOCK; SEXUAL BEHAVIOR; SIDE EFFECT; SINGAPORE; STEVENS JOHNSON SYNDROME; STROKE; SUBDURAL HEMATOMA; SYSTEMIC LUPUS ERYTHEMATOSUS; TACHYCARDIA; THROMBOCYTOPENIA; TINNITUS; UNCONSCIOUSNESS; URINE COLOR; URINE INCONTINENCE; URTICARIA; VASCULITIS; VOMITING; WEIGHT REDUCTION; WHEEZING;

COMPLEMENTARY THERAPIES; DATABASES, FACTUAL; DIETARY SUPPLEMENTS; DRUG CONTAMINATION; HOSPITALIZATION; HUMANS; PHARMACOVIGILANCE; SINGAPORE; TIME FACTORS;

EID: 84863433863     PISSN: 15563650     EISSN: 15569519     Source Type: Journal    
DOI: 10.3109/15563650.2012.700402     Document Type: Review

References (44)

1. National Center for Complementary and Alternative Medicine. What is complementary and alternative medicine? [online]. Available from URL: http://nccam.nih.gov/health/whatiscam/. Accessed 5 January, 2012.
2. Mosihuzzaman M, Choudhary MI. Protocols on safety, eff cacy, standardization, and documentation of herbal medicine (IUPAC Technical Report). Pure Appl Chem 2008; 80:2195-2230.
3. Morrow JD, Edeki TI, El Mouelhi M, Galinsky RE, Kovelesky R, Noveck RJ, Preuss C. American Society for Clinical Pharmacology and Therapeutics position statement on dietary supplement safety and regulation. Clin Pharmacol Ther 2005; 77:113-122.
4. Heng CW. MOH budget speech (part 3)-care in community. Singapore: Ministry of Health [online]; Available from URL: http://www.moh.gov. sg/mohcorp/speeches.aspx?id = 12396. Accessed 15 October 2011.
5. Loh CH. Use of traditional Chinese medicine in Singapore children: perceptions of parents and paediatricians. Singapore Med J 2009; 50:1162-1168.
6. PZ4970 INFOSEARCH-Chinese Proprietary Medicine. Health Sciences Authority Singapore [online]. Available from URL: http://eservice.hsa.gov.sg/prism/ common/enquirepublic/SearchCPProduct. do?action = load. Accessed 2011, April 20.
7. Smart and safe use of Chinese Proprietary Medicine. Health Sciences Authority Singapore. [online]. Available from URL: http://www.hsa. gov.sg/publish/hsaportal/en/for-public/consumer-guides/Smart- and-safe-use-of-CPM.html. Accessed 5 April 2012.
8. Regulatory framework. Health Products Regulation. Health Sciences Authority Singapore. [online]. Available from URL: http://www. hsa.gov.sg/publish/hsaportal/en/health-products-regulation/complementary- medicines/chinese-medicines/regulatory- frameworkhtml. Accessed 5 April 2012.
9. Woolf AD. Safety evaluation and adverse events monitoring by poison control centers: a framework for herbs & dietary supplements. Clin Toxicol (Phila) 2006; 44:617-622.
10. Van Breemen RB, Fong HH, Farnsworth NR. Ensuring the safety of botanical dietary supplements. Am J Clin Nutr 2008; 87:509S-513S.
11. Stickel F, Patsenker E, Schuppan D. Herbal hepatotoxicity. J Hepatol 2005; 43:901-910.
12. Tovar RT, Petzel RM. Herbal toxicity. Dis Mon 2009; 55:592-641.
13. Glossary of terms in pharmacovigilance. WHO-Uppsala Monitoring Centre, Sweden [online]. Available from URL: http://www.who-umc. org/graphics/25301.pdf. Accessed 5 January 2012.
14. Willett KL, Roth RA, Walker L. Workshop overview: hepatotoxicity assessment for botanical dietary supplements. Toxicol Sci 2004; 79:4-9.
15. Walker A. The relation between voluntary notif cation and material risk in dietary supplement safety. US Food and Drug Administration; 2000. FDA docket 00N-1200.
16. Health Products Regulation, Health Sciences Authority, Singapore [online]. Available from URL: http://www.hsa.gov.sg/publish/hsa-portal/en/ health-products-regulation/Report-Adverse-Events.html. Accessed 5 January 2012.
17. The WHO Adverse Reaction Terminology-WHO-ART. WHO-Uppsala Monitoring Centre, Sweden [online]. Available from URL: http://www.umc-products.com/ graphics/3149.pdf. Accessed 5 January 2012.
18. HSA detects fenf uramine, a controlled substance, in the Chinese Proprietary Medicine " Slim10 ". [Press release]. 2002, April 30 [online]. Available from http://www.hsa.gov.sg/publish/etc/medialib/hsa-library/ corporate/press-release-2002.Par.12028.File.tmp/PRelease- HSA%20Detects%20Fenfluramine%20in%20Slim10-30April02. pdf. Accessed 5 January 2012.
19. Lau G, Lo DS, Yao YJ, Leong HT, Chan CL, Chu SS. A fatal case of hepatic failure possibly induced by nitrosofenf uramine: a case report. Med Sci Law 2004; 44:252-263.
20. HSA cautions consumers against taking an Indian traditional medicine " Endopile capsules ". Health Sciences Authority, Singapore [Press Release]. 2006 August 28. Available from: http://www.hsa.gov. sg/publish/etc/medialib/hsa-library/corporate/press-release-2006. Par.48799.File.tmp/HSACautionsConsumersAgainstTakingAn- IndianTraditionalMedicine-EndopileCapsules.pdf. Accessed 5 January 2012.
21. Jacobsson I, Jonsson AK, Gerden B, Hagg S. Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. Pharmacoepidemiol Drug Saf 2009; 18:1039-1047.
22. Farah MH, Edwards R, Lindquist M, Leon C, Shaw D. International monitoring of adverse health effects associated with herbal medicines. Pharmacoepidemiol Drug Saf 2000; 9:105-112.
23. National Center for Complementary and Alternative Medicine. The use of complementary and alternative medicine in the United States. 2008 [online]. Available from: http://nccam.nih.gov/news/camstats/2007/camsurvey-fs1.htm. Accessed 5 January 2012.
24. Saokaew S, Suwankesawong W, Permsuwan U, Chaiyakunapruk N. Safety of herbal products in Thailand: an analysis of reports in the thai health product vigilance center database from 2000 to 2008. Drug Saf 2011; 34:339-350.
25. Menniti-Ippolito F, Mazzanti G, Santuccio C, Angela Moro P, Calapai G, Firenzuoli F, et al. Surveillance of suspected adverse reactions to natural health products in Italy. Pharmacoepidemiol Drug Saf 2008; 17:626-635.
26. Koh HL, Woo SO. Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugs. Drug Saf 2000; 23:351-362.
27. Chan K. Some aspects of toxic contaminants in herbal medicines. Chemosphere 2003; 52:1361-1371.
28. Li L, Low MY, Aliwarga F, Teo J, Ge XW, Zeng Y, et al. Isolation and identif cation of hydroxythiohomosildenaf l in herbal dietary supplements sold as sexual performance enhancement products. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2009; 26:145-151.
29. Low MY, Zeng Y, Li L, Ge XW, Lee R, Bloodworth BC, et al. Safety and quality assessment of 175 illegal sexual enhancement products seized in red-light districts in Singapore. Drug Saf 2009; 32:1141-1146.
30. De-Registration of Slimming Drug Preparations Containing Fenf uramine and Dexfenf uramine: Ministry of Health, Singapore [online]. Available from: http://www.moh.gov.sg/mohcorp/pressre-leases.aspx?id = 666. Accessed 5 January 2012.
31. Nakagawa Y, Suzuki T, Kamimura H, Nagai F. Role of mitochondrial membrane permeability transition in N-nitrosofenf uramine-induced cell injury in rat hepatocytes. Eur J Pharmacol 2006; 529:33-39.
32. Satoh K, Nonaka R, Tada Y, Fukumori N, Ogata A, Yamada A, et al. Effects of N-nitrosofenf uramine, a component of Chinese dietary supplement for weight loss, on CD-1 mice. Arch Toxicol 2006; 80:605-613.
33. Wai CT, Tan BH, Chan CL, Sutedja DS, Lee YM, Khor C, et al. Drug-induced liver injury at an Asian center: a prospective study. Liver Int 2007; 27:465-474.
34. Wai CT. Presentation of drug-induced liver injury in Singapore. Singapore Med J 2006; 47:116-120.
35. Ernst E. Harmless herbs? A review of the recent literature. Am J Med 1998; 104:170-178.
36. Chitturi S, Farrell GC. Hepatotoxic slimming aids and other herbal hepatotoxins. J Gastroenterol Hepatol 2008; 23:366-373.
37. Stickel F, Patsenker E, Schuppan D. Herbal hepatotoxicity. J Hepatol 2005; 43:901-910.
38. Pittler MH, Ernst E. Systematic review: hepatotoxic events associated with herbal medicinal products. Aliment Pharmacol Ther 2003; 18:451-471.
39. Chow WH, Chang P, Lee SC, Wong A, Shen HM, Verkooijen HM. Complementary and alternative medicine among Singapore cancer patients. Ann Acad Med Singapore 2010; 39:129-135.
40. Meyboom RH, Lindquist M, Egberts AC, Edwards IR. Signal selection and follow-up in pharmacovigilance. Drug Saf 2002; 25:459-465.
41. Egberts TC. Signal detection: historical background. Drug Saf 2007; 30:607-609.
42. Hu Z, Yang X, Ho PC, Chan SY, Heng PW, Chan E, et al. Herb-drug interactions: a literature review. Drugs 2005; 65:1239-1282.
43. Barnes J. Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf 2003; 26:829-851.
44. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med 1993; 328:246-252.