National surveillance of herbal dietary supplement exposures: The poison control center experience

Pharmacoepidemiology and Drug Safety

Volumn 16, Issue 9, 2007, Pages 947-957

  Gryzlak, Brian M ^a   Wallace, Robert B ^a   Zimmerman, M Bridget ^a   Nisly, Nicole L ^b  

^a UNIVERSITY OF IOWA   (United States)

^b UNIVERSITY OF IOWA   (United States)

Author keywords

Alternative medicine; Complementary medicine; Herbal dietary supplements; Integrative medicine; Post marketing surveillance

Indexed keywords

ALCOHOL; ANALGESIC AGENT; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; ANTIHISTAMINIC AGENT; ANTIINFECTIVE AGENT; ANTITUSSIVE AGENT; ANXIOLYTIC AGENT; CARDIOVASCULAR AGENT; CENTRAL STIMULANT AGENT; COSMETIC; ECHINACEA EXTRACT; ELECTROLYTE; GASTROINTESTINAL AGENT; HERBACEOUS AGENT; HOMEOPATHIC AGENT; HORMONE; HYPERICUM PERFORATUM EXTRACT; HYPNOTIC AGENT; MINERAL; MUSCLE RELAXANT AGENT; NEUROLEPTIC AGENT; NON PRESCRIPTION DRUG; PLANT EXTRACT; SEDATIVE AGENT; STREET DRUG; VITAMIN;

ADOLESCENT; ADULT; AGE DISTRIBUTION; ALTERNATIVE MEDICINE; ARTICLE; CHILD; CONTROLLED STUDY; DIET SUPPLEMENTATION; DRUG EXPOSURE; FEMALE; HERBAL MEDICINE; HUMAN; INTEGRATIVE MEDICINE; MAJOR CLINICAL STUDY; MALE; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SUICIDAL IDEATION; THERAPEUTIC ERROR; UNSPECIFIED SIDE EFFECT;

ADOLESCENT; ADULT; CHILD; CHILD, PRESCHOOL; DATABASES, FACTUAL; DIETARY SUPPLEMENTS; DRUG THERAPY; DRUG TOXICITY; ECHINACEA; FEMALE; HUMANS; HYPERICUM; MALE; PHYTOTHERAPY; POISON CONTROL CENTERS; PRODUCT SURVEILLANCE, POSTMARKETING; SUICIDE, ATTEMPTED; TIME FACTORS; UNITED STATES;

EID: 34548711355     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1445     Document Type: Article

References (55)

1. 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: 1569-1575.
2. Kelly JP, Kaufman DW, Kelley K, Rosenberg L, Anderson TE, Mitchell AA. Recent trends in use of herbal and other natural products. Arch Intern Med 2005; 165: 281-286.
3. Top-Selling Medicinal Herbs in the U.S., 1999-2003. World Almanac and Book of Facts. World Almanac Education Group Inc.: New York, 2005.
4. Ernst E. Harmless herbs? A review of the recent literature. Am J Med 1998; 104: 170-178.
5. Morris CA, Avorn J. Internet marketing of herbal products. JAMA 2003; 290: 1505-1509.
6. Izzo AA, Ernst E. Interactions between herbal medicines and prescribed drugs: a systematic review. Drugs 2001; 61: 2163-2175.
7. Dasgupta A. Review of abnormal laboratory test results and toxic effects due to use of herbal medicines. Am J Clin Pathol 2003; 120: 127-137.
8. Kinariwala N. Tighter regulation needed for dietary supplements in USA. Lancet 2003; 361: 1566.
9. Milan F, Fallek R. Current regulations of dietary supplements: DSHEA revisited. Alternative Therapies in Women's Health 2003; 5: 92-95.
10. Cohen PJ. Science, politics, and the regulation of dietary supplements: it's time to repeal DSHEA. Am J Law Med 2005; 31: 175-214.
11. Onel S. Dietary supplements: a definition that is black, white, and gray. Am J Law Med 2005; 31: 341-348.
12. Hathcock J. Dietary supplements: how they are used and regulated. J Nutr 2001; 131: 1114S-1117S.
13. Greeson JM, Sanford B, Monti DA. St. John's wort (Hypericum perforatum): a review of the current pharmacological, toxicological, and clinical literature. Psychopharmacology (Berl) 2001; 153: 402-414.
14. Ahmad SR, Goetsch RA, Marks NS. Spontaneous reporting in the United States. In Pharmacoepidemiology (4th edn), Strom BL (ed.). John Wiley & Sons, Ltd.: West Sussex, England, 2005.
15. De Smet PA. Health risks of herbal remedies. Drug Saf 1995; 13: 81-93.
16. Polivka BJ, Elliott MB, Wolowich WR. Comparison of poison exposure data: NHIS and TESS data. J Toxicol Clin Toxicol 2002; 40: 839-845.
17. 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: 391-452.
18. Kennedy J. Herb and supplement use in the US adult population. Clin Ther 2005; 27: 1847-1858.
19. Wallace RB, Zimmerman BM, Nisly NL. Analysis of herbal dietary supplements in the US using the National Health Instrument Survey. Unpublished data analyses. 2004.
20. Borchers AT, Keen CL, Stern JS, Gershwin ME. Inflammation and Native American medicine: the role of botanicals. Am J Clin Nutr 2000; 72: 339-347.
21. National Center for Complementary and Alternative Medicine. St. John's Wort and the treatment of depression. Accessed February 24, 2004; http://altmed.od.nih.gov/health/stjohnswort/
22. Palmer ME, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observational study. Lancet 2003; 361: 101-106.
23. Yang S, Dennehy CE, Tsourounis C. Characterizing adverse events reported to the California poison control system on herbal remedies and dietary supplements: a pilot study. J Herb Pharmacother 2002; 2: 1-11.
24. Dennehy CE, Tsourounis C, Horn AJ. Dietary supplement-related adverse events reported to the California poison control system. Am J Health Syst Pharm 2005; 62: 1476-1482.
25. Litovitz T. The TESS database. Use in product safety assessment. Drug Saf 1998; 18: 9-19.
26. Litovitz T, Kearney TE, Holm K, Soloway RA, Weisman R, Oderda G. Poison control centers: is there an antidote for budget cuts? Am J Emerg Med 1994; 12: 585-599.
27. American Association of Poison Control Centers (AAPCC). Toxic Exposure Surveillance System (TESS®) database: 2001 Human Exposures reported to U.S. Poison Control Centers for Generic Category Code Echinacea <201090> and St. John's wort <201095>. AAPCC: Washington, DC, 2003.
28. SAS System for Windows® 9.0. [computer program]. SAS Institute Inc.: Cary, NC, 2002.
29. US Food and Drug Administration, Center for Food Safety and Applied Nutrition. FDA Public Health Advisory: Worsening Depression and Suicidality in Patients Being Treated With Antidepressant Medications. Accessed March 13, 2004; http://www.fda.gov/cder/drug/ antidepressants/Antidepressanst-PHA.htm
30. Nanayakkara PWB, Meijboom M, Schouten JA. Suicidal and aggressive thoughts as a result of taking a Hypericum preparation (St. John's wort). Ned Tijdschr Geneeskd 2005; 149: 1347-1349.
31. Noonan K, Arensman RM, Hoover JD. Herbal medication use in the pediatric surgical patient. J Pediatr Surg 2004; 39: 500-503.
32. McGuigan MA. Common culprits in childhood poisoning: epidemiology, treatment and parental advice for prevention. Paediatr Drugs 1999; 1: 313-324.
33. Burda AM, Burda NM. The nation's first poison control center: taking a stand against accidental childhood poisoning in Chicago. Vet Hum Toxicol 1997; 39: 115-119.
34. Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. Br J Clin Pharmacol 1998; 45: 496-500.
35. Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA 1999; 281: 824-829.
36. Barrett B. Medicinal properties of Echinacea: a critical review. Phytomedicine 2003; 10: 66-86.
37. Huntley AL, Thompson Coon J, Ernst E. The safety of herbal medicinal products derived from Echinacea species: a systematic review. Drug Saf 2005; 28: 387-400.
38. Soon SL, Crawford RI. Recurrent erythema nodosum associated with Echinacea herbal therapy. J Am Acad Dermatol 2001; 44: 298-299.
39. Taylor JA, Weber W, Standish L, et al. Efficacy and safety of Echinacea in treating upper respiratory tract infections in children: a randomized controlled trial. JAMA 2003; 290: 2824-2830.
40. Mullins RJ, Heddle R. Adverse reactions associated with echinacea: the Australian experience. Ann Allergy Asthma Immunol 2002; 88: 42-51.
41. Rodriguez-Landa JF, Contreras CM. A review of clinical and experimental observations about antidepressant actions and side effects produced by Hypericum perforatum extracts. Phytomedicine 2003; 10: 688-699.
42. Muller WE. Current St. John's wort research from mode of action to clinical efficacy. Pharmacol Res 2003; 47: 101-109.
43. Schulz V. Incidence and clinical relevance of the interactions and side effects of hypericum preparations. Phytomedicine 2001; 8: 152-160.
44. Veltri JC, McElwee NE, Schumacher MC. Interpretation and uses of data collected in poison control centres in the United States. Med Toxicol Adverse Drug Exp 1987; 2: 389-397.
45. Linakis JG, Frederick KA. Poisoning deaths not reported to the regional poison control center. Ann Emerg Med 1993; 22: 1822-1828.
46. Clark RF, Phillips M, Manoguerra AS, Chan TC. Evaluating the utilization of a regional poison center by Latino communities. J Toxicol Clin Toxicol 2002; 40: 855-860.
47. Vassilev ZP, Marcus S, Jennis T, Ruck B, Swenson R, Rego G. Rapid communication: sociodemographic differences between counties with high and low utilization of a regional poison control center. J Toxicol Environ Health A 2003; 66: 1905-1908.
48. Kelly NR, Groff JY. Exploring barriers to utilization of poison centers: a qualitative study of mothers attending an urban women, infants, and children (WIC) clinic. Pediatrics 2000; 106: 199-204.
49. Brannan JE. Accidental poisoning of children: barriers to resource use in a Black, low-income community. Public Health Nurs 1992; 9: 81-86.
50. Harkey MR, Henderson GL, Gershwin ME, Stern JS, Hackman RM. Variability in commercial ginseng products: an analysis of 25 preparations. Am J Clin Nutr 2001; 73: 1101-1106.
51. Draves AH, Walker SE. Analysis of the hypericin and pseudohypericin content of commercially available St John's Wort preparations. Can J Clin Pharmacol 2003; 10: 114-118.
52. Institute of Medicine, Committee on Poison Prevention and Control. Forging a Poison Prevention and Control System. The National Academies Press: Washington, DC, 2004.
53. Chyka P. Role of US poison centers in adverse drug reactions monitoring. Vet Hum Toxicol 1999; 41: 400-402.
54. Institute of Medicine, National Research Council. Dietary Supplements: A Framework for Evaluating Safety. National Academies Press: Washington DC, 2004.
55. Dietary Supplement and Nonprescription Drug Consumer Protection Act. Public Law 109-462. Enacted December 22, 2006.