Surveillance of suspected adverse reactions to natural health products in Italy

Pharmacoepidemiology and Drug Safety

Volumn 17, Issue 6, 2008, Pages 626-635

  Menniti Ippolito, Francesca ^a   Mazzanti, Gabriela ^b   Santuccio, Carmela ^c   Moro, Paola Angela ^d   Calapai, Gioacchino ^e   Firenzuoli, Fabio ^f   Valeri, Andrea ^g   Raschetti, Roberto ^a  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^b SAPIENZA UNIVERSITY OF ROME   (Italy)

^c ITALIAN MEDICINES AGENCY   (Italy)

^d OSPEDALE NIGUARDA CA GRANDA   (Italy)

^e UNIVERSITY OF MESSINA   (Italy)

^f SAN GIUSEPPE HOSPITAL   (Italy)

^g Italian Society for Homeopathic Medicine   (Italy)

Author keywords

Adverse reactions; Herbal medicine; Natural products; Surveillance

Indexed keywords

AMINOBENZOIC ACID; BRONCOSEDINA; BUSPIRONE; CASEIN; CHELIDONIUM EXTRACT; CHINESE DRUG; COLEUS FORSKOLII EXTRACT; COPPER; DEANOL; DEGLYCYRRHIZINATED LIQUORICE; DICHROMATE POTASSIUM; EPHEDRA SINICA EXTRACT; GINKGO BILOBA EXTRACT; HERBACEOUS AGENT; HOODIA EXTRACT; JIN BU HUAN; LEAD SULFIDE; MACULAR; MERCURIC CHLORIDE; METFORMIN; MONTELUKAST; NATURAL PRODUCT; PLANT EXTRACT; PROPOLIS; SELENIUM; TROPANE ALKALOID; VITAMIN; XANTHOPHYLL; ZINC; BIOLOGICAL PRODUCT; MATERIA MEDICA; PLANT MEDICINAL PRODUCT;

ABDOMINAL PAIN; ACUTE HEPATITIS; ACUTE PSYCHOSIS; AD HOC STUDY; ALLERGIC REACTION; ANGIONEUROTIC EDEMA; ANTICHOLINERGIC SYNDROME; ANXIETY DISORDER; ARTICLE; CARDIOTOXICITY; CHRONIC HEPATITIS; CITATION ANALYSIS; CONFUSION; CONVULSION; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DUODENUM ULCER; DYSPEPSIA; EYE DISEASE; FACE EDEMA; GASTROINTESTINAL TOXICITY; HALLUCINATION; HEPATITIS; HUMAN; ITALY; LIVER FAILURE; LIVER TOXICITY; MENTAL DISEASE; METABOLIC DISORDER; NAUSEA; NEUROTOXICITY; PRIORITY JOURNAL; PRURITUS; RESTLESSNESS; RHABDOMYOLYSIS; SKIN TOXICITY; STATISTICAL ANALYSIS; SYSTEMIC DISEASE; VASCULAR DISEASE; VOMITING; ADOLESCENT; ADULT; AGED; CHILD; FEMALE; HOSPITALIZATION; INFANT; MALE; MIDDLE AGED; PHARMACOEPIDEMIOLOGY; PHYTOTHERAPY; PRESCHOOL CHILD; STATISTICS;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AGED, 80 AND OVER; BIOLOGICAL PRODUCTS; CHILD; CHILD, PRESCHOOL; FEMALE; HEPATITIS; HOSPITALIZATION; HUMANS; INFANT; ITALY; MALE; MATERIA MEDICA; MIDDLE AGED; PHARMACOEPIDEMIOLOGY; PHYTOTHERAPY; PLANT PREPARATIONS; PROPOLIS;

EID: 46349106970     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1566     Document Type: Article

References (39)

1. Ernst E. The Desktop Guide to Complementary Alternative Medicine. Hartcourt Publishers Limited: London 2001.
2. Firenzuoli F. Fitoterapia [in Italian]. Masson: Milano, 2002.
3. Capasso F, Gaginella TS, Grandolini G, Izzo AA. Phytotherapy - A Quick Reference to Herbal Medicine. Springer:. Milan, 2003.
4. Thomas K, Coleman P. Use of complementary or alternative medicine in a general population in Great Britain. Results from the National Omnibus Survey. J Public Health 2004; 26(2): 152-157.
5. Yu SM, Ghandour RM, Huang ZJ. Herbal supplement use among US women, 2000. J Am Med Womens Assoc 2004; 59(1): 17-24.
6. Barnes J. Quality, efficacy and safety of complementary medicine: fashions, facts and the future. Part I. Regulation and quality. Br J Clin Pharmacol 2003; 55: 226-233.
7. Busse W. The significance of quality for efficacy and safety of herbal medicinal products. Drug Inform J 2000; 34: 15-23.
8. De Smet PA. Clinical risk management of herb-drug interactions. Br J Clin Pharmacol 2007; 63(3): 258-267.
9. Ernst E. Heavy metals in traditional Indian remedies. Eur J Clin Pharmacol 2002; 57(12): 891-896.
10. Ko R. Safety of ethnic and imported herbal and dietary supplements. Clin Toxicol 2006; 44(5): 611-616.
11. Woodward KN. The potential impact of the use of homeopathic and herbal remedies on monitoring the safety of prescription products. Hum Exp Toxicol 2005; 24: 219-233.
12. Kirby BJ. Safety of homeopathic products. J Royal Soc Med 2002; 95(5): 221-222.
13. Mortelmans LJM, Biesemans L, Rossom PV. Homeopathic products, not as innocent and safe as they seem? A case report. Eur J Emerg Med 2004; 11: 242-243.
14. Ernst E. Harmless herb? A review of the recent literature. Am J Med 1998 104: 170-178.
15. Ibrahim AS, Latif AH. Adult lead poisoning from herbal medicine. Saudi Med J 2002; 23: 591-593.
16. Furbee RB, Barlotta KS, Allen MK, Holstege CP. Hepatotoxicity associated with herbal products. Clin Med Lab 2006; 26(1): 227-241.
17. Chavez ML, Jordan MA, Chavez PI. Evidence-based drug-herbal interactions. Life Sci 2006; 78(18): 2146-2157.
18. Woolf GM, Petrovic LM, Roiter SE, et al. Acate hepatitis associated with Chinese herbal product Jin Bu Huan. Ann Intern Med 1994; 121: 729-735.
19. Picciotto A, Campo N, Brizzolara R, et al. Chronic hepatitis induced by Jin Bu Huan. J Hepatol 1998; 28: 165-167.
20. Stickel F, Poschl G, Seitz HK, et al. Acute hepatitis induced by Greater Celandine (Chelidonium majus). Scand J Gastroenterol 2003 38(5): 565-568.
21. Benninger J, Schneider HT, Schuppan D, et al. Acute hepatitis induced by greater celandine (Chelidonium majus). Gastroenterol 1999; 117: 1234-1237.
22. Crijns AP, de Smet PA, van den Heuvel M, et al. Acute hepatitis after use of a herbal preparation with greater celandine (Chelidonium majus) [in Dutch]. Ned Tijdschr Geneeskd 2002; 146(3): 124-128.
23. Actis GC, Bugianesi E, Ottobrelli A, Rizzetto M. Fatal liver failure following food supplements during chronic treatment with montelukast. Dig Liver Dis 2007; 39: 953-955.
24. Audicana M, Bernedo N, Gonzales I, et al. An unusual case of baboon sindrome due to mercury present in a homeopathic medicine. Contact Dermatitis 2001; 45: 185.
25. Montoya-Cabrera MA, Rubio-Rodriguez S, Velazquez-Gonazales E, et al. Mercury poisoning by a homeopatic drug [in Spanish]. Gac Med Mex 1991; 127(3): 267-270.
26. Van Ulsen J, Stolz E, Van Joost T. Chromate dermatitis from a homeopathic drug. Contact Dermatitis 1988; 18(1): 56-57.
27. Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the food and drug administration, 1998-2005. Arch Intern Med 2007; 167: 1752-1759.
28. Alvarez-Requejo A, Carvajal A, Bégaud B, et al. Under-reporting of adverse drug reactions. Eur J Clin Pharmacol 1998; 54: 483--489.
29. Barnes J. Pharmacovigilance of herbal medicines. Drug Saf 2003; 26: 829-851.
30. Menniti-Ippolito F, Gargiulo L, Bologna E, et al. Use of unconventional medicine in Italy: a nation-wide survey. Eur J Clin Pharmacol 2002; 58: 61-64.
31. Menniti-Ippolito F, Forcella E, Bologna E, Gargiulo L, Traversa G, Raschetti R. Use of unconventional medicine in children in Italy. Eur J Pediatrics 2002; 161: 690.
32. Reider N, Sepp N, Fritsch P, et al. Anaphylaxis to chamomile: clinical features and allergen cross-reactivity. Clin Exp Allergy 2000; 30: 1436--1443.
33. Chivato T, Juan F, Montoro A, et al. Anaphylaxis induced by the ingestion of a pollen compound. J Investig Allergol Clin Immunol 1996; 6: 208-209.
34. Greenberg P, Fiais M. Bee pollen-induced anaphylactic reaction in an unkwnowingly sensitised subjects. Ann Allergy Asthma Immunol 2001; 86: 239-242.
35. Thien FCK, Leung R, Baldo BA, et al. Asthma and anaphylaxis induced by royal jelly. Clin Exp Allergy 1996; 26: 216-222.
36. Hausen BM, Wollenweber E, Senff H, et al. Propolis allergy (1) origin, properties, usage and literature review. Contact Dermatitis 1987; 17: 163-170.
37. Zaffani S, Cuzzolin L, Benoni G. Herbal products: behaviours and beliefs among Italian women. Pharmacoepidemiol Drug Saf 2006 15(5): 354-359.
38. Barnes J, Anderson LA, Phillipson JD. Herbal Medicines. Pharmaceutical Press: London, 2002.
39. Gardner DR, Panter KE, James LF, Stegelmeier BL. Abortifacient effects of lodgepole pine (Pinus contorta) and common juniper (Juniperus communis) on cattle. Vet Hum Toxicol 1998; 40: 260-263.