Safety assurances for dietary supplements: Policy issues and new research paradigms

Journal of Herbal Pharmacotherapy

Volumn 5, Issue 1, 2005, Pages 3-15

  Basch, Ethan M ^a   Servoss, Julie C ^b   Tedrow, Usha B ^c  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450; EPHEDRA EXTRACT; GINKGO BILOBA EXTRACT; HERBACEOUS AGENT; HYPERICUM PERFORATUM EXTRACT; KAVA EXTRACT; NUTRACEUTICAL; TROGLITAZONE; WARFARIN;

ALTERNATIVE MEDICINE; ARTICLE; CEREBROVASCULAR ACCIDENT; CHRONIC DISEASE; CLINICAL STUDY; DIABETES MELLITUS; DIET SUPPLEMENTATION; DRUG APPROVAL; DRUG EFFICACY; DRUG FATALITY; DRUG INFORMATION; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; DRUG UTILIZATION; ECONOMIC EVALUATION; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HEART INFARCTION; HEPATITIS; HERB DRUG INTERACTION; HERBAL MEDICINE; HUMAN; LIVER CIRRHOSIS; LIVER FAILURE; LIVER INJURY; MEDICAL EDUCATION; MENTAL DISEASE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SEIZURE; SIDE EFFECT; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CONSUMER PRODUCT SAFETY; DIETARY SUPPLEMENTS; FOOD LABELING; HEALTH EDUCATION; HEALTH POLICY; HEALTH PROMOTION; HUMANS; MEDICINE, HERBAL; PHYTOTHERAPY; PLANT PREPARATIONS; RESEARCH DESIGN; UNITED STATES;

EID: 27544437889     PISSN: 15228940     EISSN: None     Source Type: Journal    
DOI: 10.1300/J157v05n01_02     Document Type: Article

References (73)

1. Dietary Supplement Health and Education Act of 1994 (DSHEA). Public Law 103-417, October 25, 1994 (103rd Congress).
2. Astin JA, Marie A, Pelletier KR, et al. A review of the incorporation of complementary and alternative medicine by mainstream physicians. Arch Intern Med 1998;158(21):2303-2310.
3. Astin JA. Why patients use alternative medicine: results of a national study. JAMA 1998;279(19):1548-1553.
4. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: Results of a follow-up national survey. JAMA 1998; 280(18):1569-1575.
5. Druss BG, Rosenheck RA. Association between use of unconventional therapies and conventional medical services. JAMA 1999;282(7):651-656.
6. Harnack LJ, Rydell SA, Stang J. Prevalence of use of herbal products by adults in the Minneapolis/St Paul, Minn, metropolitan area. Mayo Clin Proc 2001;76(7): 688-694.
7. Basch EM, Ulbricht CE. Complementary, alternative, and integrative therapies in cancer care. In: Devita VT, Hellman S, Rosenberg SA (eds.). Cancer: Principles & Practice of Oncology (7th edition). Philadelphia, PA: Lippincott Williams and Wilkins, 2004.
8. Jonas WB. Alternative medicine - learning from the past, examining the present, advancing to the future. JAMA 1998;280(18):1616-1618.
9. Angell M, Kassirer JP. Alternative medicine - the risks of untested and unregulated remedies. N Engl J Med 1998;339(12):839-841.
10. Studdert DM, Eisenberg DM, Miller FH, et al. Medical malpractice implications of alternative medicine. JAMA 1998;280(18):1610-1615.
11. Corbin WL, Shapiro H. Physicians want education about complementary and alternative medicine to enhance communication with their patients. Arch Intern Med 2002; 162(10):1176-1181.
12. Kroll DJ. Concerns and needs for research in herbal supplement pharmacotherapy and safety. Journal of Herbal Pharmacotherapy 2001;1(2):3-23.
13. Palmer ME, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observational study. Lancet 2003;361(9352):101-106.
14. Fugh-Berman A. Herb-drug interactions. Lancet 2000;355(9198):134-138.
15. Lambrecht J, Hamilton W, Rabinovich A. A review of herb-drug interactions: documented and theoretical. US Pharmacist 2000;25(8):1-12.
16. Abebe W. Herbal medication: potential for adverse interactions with analgesic drugs. J Clin Pharm Ther 2002;27(6):391-401.
17. Ernst E. Possible interactions between synthetic and herbal medicinal products. Part 1: A systematic review of the indirect evidence. Perfusion 2000;13:4-15.
18. Izzo AA, Ernst E. Interactions between herbal medicines and prescribed drugs: A systematic review. Drugs 2001;61(15):2163-2175.
19. Piscitelli SC, Burstein AH. Herb-drug interactions and confounding in clinical trials. Journal of Herbal Pharmacotherapy 2002;2(1):23-26.
20. Hardy ML. Herb-drug interactions: An evidence-based table. Alternative Medicine Alert 2000;June:64-69.
21. Rogers EA, Gough JE, Brewer KL. Are emergency department patients at risk for herb-drug interactions? Acad Emerg Med 2001;8(9):932-934.
22. Ang-Lee MK, Moss J, Yuan CS. Herbal medicines and perioperative care. JAMA 2001;286(2):208-216.
23. Farah MH, Edwards R, Lindquist M, et al. International monitoring of adverse health effects associated with herbal medicines. Pharmacoepidemiol Drug Safety 2000;9:105-112.
24. Blumenthal M, Steele E. DSHEA at five years: A review of structure-function claims. HerbalGram 1999;47:38-39.
25. Dickinson A. The relative safety of ephedra compared with other herbal products. Ann Intern Med 2003;139(5 Pt 1):385-387.
26. Fontanarosa PB, Rennie D, DeAngelis CD. The need for regulation of dietary supplements - lessons from ephedra. JAMA 2003;289(12):1568-1570.
27. Anon. Kava: first suspended, now prohibited. Prescrire Int 2003;12(66):142.
28. Anon. From the Centers for Disease Control and Prevention. Hepatic toxicity possibly associated with kava-containing products - United States, Germany, and Switzerland, 1999-2002. JAMA 2003;289(1):36-37.
29. Boon HS, Wong AH. Kava: A test case for Canada's new approach to natural health products. CMAJ 2003;169(11):1163-1164.
30. Barone GW, Gurley BJ, Ketel BL, et al. Drug interaction between St. John's wort and cyclosporine. Ann Pharmacother 2000;34(9):1013-1016.
31. De Smet PA, Touw DJ. Safety of St John's wort (Hypericum perforatum). Lancet 2000;355(9203):575-576.
32. Henney J. Risk of drug interactions with St. John's wort. JAMA 2000;283(13):1.
33. Jobst KA, McIntyre M, St George D, et al. Safety of St. John's wort (Hypericum perforatum). Lancet 2000;355(9203):575.
34. Markowitz JS, DeVane CL, Boulton DW, et al. Effect of St. John's wort (Hypericum perforatum) on cytochrome P-450 2D6 and 3A4 activity in healthy volunteers. Life Sci 2000;66(9):L133-L139.
35. Piscitelli SC, Burstein AH, Chaitt D, et al. Indinavir concentrations and St. John's wort. Lancet 2000;355(9203):547-548.
36. Roby CA, Anderson GD, Kantor E, et al. St. John's wort: Effect on CYP3A4 activity. Clin Pharmacol Ther 2000;67(5):451-457.
37. Ruschitzka F, Meier PJ, Turina M, et al. Acute heart transplant rejection due to Saint John's wort. Lancet 2000;355(9203):548-549.
38. Yuan CS, Wei G, Dey L, et al. Brief communication: American ginseng reduces warfarin's effect in healthy patients: a randomized, controlled Trial. Ann Intern Med 2004;141(1):23-27.
39. Janetzky K, Morreale AP. Probable interaction between warfarin and ginseng. Am J Health Syst Pharm 1997;54(6):692-693.
40. Benjamin J, Muir T, Briggs K, et al. A case of cerebral haemorrhage - can Ginkgo biloba be implicated? Postgrad Med J 2001;77(904):112-113.
41. Kim YS, Pyo MK, Park KM, et al. Antiplatelet and antithrombotic effects of a combination of ticlopidine and Ginkgo biloba ext (EGb 761). Thromb Res 1998; 91(1):33-38.
42. Matthews MK, Jr. Association of Ginkgo biloba with intracerebral hemorrhage. Neurology 1998;50(6):1933-1934.
43. Skogh M. Extracts of Ginkgo biloba and bleeding or haemorrhage. Lancet 1998;352(9134):1145-1146.
44. Vale S. Subarachnoid haemorrhage associated with Ginkgo biloba. Lancet 1998;352(9121):36.
45. Rowin J, Lewis SL. Spontaneous bilateral subdural hematomas associated with chronic Ginkgo biloba ingestion. Neurology 1996;46(6):1775-1776.
46. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. Online letter announcing closure of Special Nutritional Adverse Event Monitoring System (August 29, 2004). http://vm.cfsan.fda.gov/~dms/aems.html (last accessed July 15, 2004).
47. Litovitz TL, Klein-Schwartz W, Rodgers GC, Jr., et al. 2001 Annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med 2002;20(5):391-452.
48. Charatan F. Ephedra supplement may have contributed to sportsman's death. BMJ 2003;326(7387):464.
49. Shekelle P, Morton S, Maglione M, et al. Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects. Evidence Report/Technology Assessment No. 76 (Prepared by Southern California Evidence-based Practice Center, RAND, under Contract No 290-97-0001, Task Order No. 9). Agency for Healthcare Research and Quality. Rockville, MD. February, 2003.
50. Shekelle PG, Hardy ML, Morton SC, et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: A meta-analysis. JAMA 2003; 289(12):1537-1545.
51. Bent S, Tiedt TN, Odden MC, et al. The relative safety of ephedra compared with other herbal products. Ann Intern Med 2003;138(6):468-471.
52. Kingston RL, Borron SW. The relative safety of ephedra compared with other herbal products. Ann Intern Med 2003;139(5 Pt 1):385-387.
53. Dickinson A. The relative safety of ephedra compared with other herbal products. Ann Intern Med 2003;139(5 Pt 1):385-387.
54. Whitaker JM. The relative safety of ephedra compared with other herbal products. Ann Intern Med 2003;139(5 Pt 1):385-387.
55. Kimmel SE. The relative safety of ephedra compared with other herbal products. Ann Intern Med 2003;139(3):234.
56. Kalman DS, Antonio J, Kreider RB. The relative safety of ephedra compared with other herbal products. Ann Intern Med 2003;138(12):1006-1007.
57. Stafford N. Germany may ban kava kava herbal supplement, Reuter's News Service Germany (November 19, 2001).
58. Mills E, Singh R, Ross C, et al. Sale of kava extract in some health food stores. CMAJ 2003;169(11):1158-1159.
59. Schulze J, Raasch W, Siegers CP. Toxicity of kava pyrones, drug safety and precautions - a case study. Phytomedicine 2003;10 Suppl 4:68-73.
60. Ernst E. [Recall of the herbal anxiolytic kava. Underestimation of its value or overestimation of its risks?]. MMW Fortschr Med 2002;144(41):40.
61. Bujanda L, Palacios A, Silvarino R, et al. Kava-induced acute icteric hepatitis. Gastroenterol Hepatol 2002;25(6):434-435.
62. Humberston CL, Akhtar J, Krenzelok EP. Acute hepatitis induced by kava kava. J Toxicol Clin Toxicol 2003;41(2):109-113.
63. Stickel F, Baumuller HM, Seitz K, et al. Hepatitis induced by kava (Piper methysticum rhizoma). J Hepatol 2003;39(1):62-67.
64. Escher M, Desmeules J, Giostra E, et al. Hepatitis associated with kava, a herbal remedy for anxiety. BMJ 2001;322(7279):139.
65. Kraft M, Spahn TW, Menzel J, et al. [Fulminant liver failure after administration of the herbal antidepressant Kava-Kava]. Dtsch Med Wochenschr 2001;126 (36):970-972.
66. Thomsen M, Vitetta L, Schmidt M, et al. Fatal fulminant hepatic failure induced by a natural therapy containing kava. Med J Aust 2004;180(4):198-199.
67. Gow PJ, Connelly NJ, Hill RL, et al. Fatal fulminant hepatic failure induced by a natural therapy containing kava. Med J Aust 2003;178(9):442-443.
68. Anon. Relevant hepatotoxic effects of kava still need to be proven. A statement of the Society for Medicinal Plant Research. Planta Med 2003;69(11):971-972.
69. Denham A, McIntyre M, Whitehouse J. Kava - the unfolding story: Report on a work-in-progress. J Altern Complement Med 2002;8(3):237-263.
70. Parkman CA. Another FDA warning: Kava supplements. Case Manager 2002; 13(4):26-28.
71. Center for Food Safety and Applied Nutrition (US Food and Drug Administration). Kava-containing dietary supplements may be associated with severe liver injury (document issued March 25, 2002).
72. Center for Food Safety and Applied Nutrition (US Food and Drug Administration). Letter to health care professionals: FDA issues consumer advisory that kava products may be associated with severe liver injury (document issued March 25, 2002), contact information for FDA Medwatch program: 1-800-332-1088.
73. Tubert-Bitter P, Begaud B, Moride Y, et al. Comparing the toxicity of two drugs in the framework of spontaneous reporting: A confidence interval approach. J Clin Epidemiol 1996;49(1):121-123.