Signal detection for Thai traditional medicine: Examination of national pharmacovigilance data using reporting odds ratio and reported population attributable risk

Regulatory Toxicology and Pharmacology

Volumn 70, Issue 1, 2014, Pages 407-412

  Wechwithan, Sareeya ^a,b   Suwankesawong, Wimon ^a   Sornsrivichai, Vorasith ^b   McNeil, Edward B ^b   Jiraphongsa, Chuleeporn ^a   Chongsuvivatwong, Virasakdi ^b  

^a MINISTRY OF PUBLIC HEALTH   (Thailand)

^b PRINCE OF SONGKLA UNIVERSITY   (Thailand)

Author keywords

ADR; Herbal medicine; Reporting odds ratio; Serious ADR; Thai traditional medicine

Indexed keywords

ALLOPURINOL; AMLODIPINE; AMOXICILLIN; ANDROGRAPHIS PANICULATA EXTRACT; ARTHROSPIRA PLATENSIS EXTRACT; BLACK PEPPER EXTRACT; CARBAMAZEPINE; CASSIA ANGUSTIFOLIA EXTRACT; CEFTRIAXONE; CLINACANTHUS NUTAN EXTRACT; COTRIMOXAZOLE; CURCUMA LONGA EXTRACT; CURCUMA XANTHORRHIZA EXTRACT; DERRIS SCANDENS EXTRACT; DICLOFENAC; DORZOLAMIDE PLUS TIMOLOL; GANODERMA LUCIDUM EXTRACT; GINKGO BILOBA EXTRACT; HERBACEOUS AGENT; HOUTTUYNIA CORDATA EXTRACT; MOMORDICA CHARANTIA EXTRACT; MYRISTICA FRAGRANS EXTRACT; PENICILLIN G; PLANT EXTRACT; POGOSTEMON CABLIN EXTRACT; SOLANUM TRILOBATUM EXTRACT; SOPHORA EXIGUA EXTRACT; TALINUM PANICULATA EXTRACT; TIONSPORA CRISPA EXTRACT; UNCLASSIFIED DRUG; UNINDEXED DRUG; PLANT MEDICINAL PRODUCT;

ADVERSE DRUG REACTION; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ARTICLE; ATTRIBUTABLE RISK; CASSIA; CASSIA ANGUSTIFOLIA; DERRIS; DERRIS SCANDENS; DIARRHEA; DIZZINESS; DRUG SURVEILLANCE PROGRAM; FACE EDEMA; FOOD AND DRUG ADMINISTRATION; GREEN TRADITIONAL MEDICINE; HUMAN; MEDICINAL PLANT; NAUSEA; POPULATION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; SIGNAL DETECTION; SOPHORA; SOPHORA EXIGUA; STEVENS JOHNSON SYNDROME; TALINUM PANICULATA; THAI TRADITIONAL MEDICINE; TIONSPORA CRISPA; TRADITIONAL MEDICINE; UNSPECIFIED SIDE EFFECT; URTICARIA; VOMITING; ADVERSE EFFECTS; CHEMISTRY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FACTUAL DATABASE; ORIENTAL MEDICINE; RISK; STATISTICS AND NUMERICAL DATA; THAILAND;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; MEDICINE, EAST ASIAN TRADITIONAL; ODDS RATIO; PHARMACOVIGILANCE; PLANT PREPARATIONS; PLANTS, MEDICINAL; THAILAND;

EID: 84944210116     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2014.06.007     Document Type: Article

References (41)

1. Aagaard L., et al. Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006. Drug Saf. 2009, 32(11):1067-1074.
2. Al-Windi A. Predictors of herbal medicine use in a Swedish health practice. Pharmacoepidemiol. Drug Saf. 2004, 13(7):489-496.
3. AlBraik F.A., et al. A cross-sectional survey of herbal remedy taking by United Arab Emirate (UAE) citizens in Abu Dhabi. Pharmacoepidemiol. Drug Saf. 2008, 17(7):725-732.
4. Aldea A., et al. Paediatric adverse drug reactions reported to the Spanish pharmacovigilance system from 2004 to 2009. Eur. J. Clin. Pharmacol. 2012, 68(9):1329-1338.
5. Barvaliya M., et al. Drug-induced Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS-TEN overlap: a multicentric retrospective study. J. Postgrad. Med. 2011, 57(2):115-119.
6. Davis M.A., Weeks W.B. The concentration of out-of-pocket expenditures on complementary and alternative medicine in the United States. Altern. Ther. Health Med. 2012, 18(5):36-42.
7. de Langen J., et al. Adverse drug reaction reporting by patients in The Netherlands three years of experience. Drug Saf. 2008, 31(6):515-524.
8. Farah M.H., et al. International monitoring of adverse health effects associated with herbal medicines. Pharmacoepidemiol. Drug Saf. 2000, 9(2):105-112.
9. Geier J., et al. Anaphylactic shock due to an extract of Silybum marianum in a patient with immediate-type allergy to kiwi fruit. Allergologie 1990, 13(10):387-388.
10. Harrer A., et al. Diclofenac hypersensitivity: antibody responses to the parent drug and relevant metabolites. PLoS One 2010, 5(10):e13707.
11. Hom K.A., et al. Antihypertensive drug-induced angioedema causing upper airway obstruction in children. Int. J. Pediatr. Otorhinolaryngol. 2012, 76(1):14-19.
12. Ji K.M., et al. Anaphylactic shock and lethal anaphylaxis caused by Houttuynia cordata injection, a herbal treatment in China. Allergy 2009, 64(5):816-817.
13. Joos S., et al. Herbal medicine in primary healthcare in Germany: the patient's perspective. Evid. Based Complement. Altern. Med. 2012, 2012.
14. Kaplan A.P., Greaves M.W. Angioedema. J. Am. Acad. Dermatol. 2005, 53(3):373-388.
15. Kashani L., et al. Knowledge, attitude and practice of herbal remedies in a group of infertile couples. Acta Med. Iran. 2013, 51(3).
16. Kim J., et al. Signal detection of methylphenidate by comparing a spontaneous reporting database with a claims database. Regul. Toxicol. Pharmacol. 2011, 61(2):154-160.
17. Kulkantrakorn K., et al. HLA-B*1502 strongly predicts carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in Thai patients with neuropathic pain. Pain Pract. 2012, 12(3):202-208.
18. Kuptniratsaikul V., et al. Efficacy and safety of Derris scandens Benth extracts in patients with knee osteoarthritis. J. Altern. Complement. Med. 2011, 17(2):147-153.
19. Mandel G., et al. Mandell, Douglas, and Bennet's Principles and Practice of Infectious Diseases 2000, Churchill Livingstone, Philadelphia.
20. Menniti-Ippolito F., et al. Surveillance of suspected adverse reactions to natural health products in Italy. Pharmacoepidemiol. Drug Saf. 2008, 17(6):626-635.
21. Nagayama M., et al. Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension. Clin. Ophthalm. (Auckland, NZ) 2014, 8:219-228.
22. Naranjo C.A., et al. A method for estimating the probability of adverse drug reactions. Clin. Pharmacol. Ther. 1981, 30(2):239-245.
23. Naveen K.N., et al. Retrospective analysis of Steven Johnson syndrome and toxic epidermal necrolysis over a period of 5 years from northern Karnataka, India. Indian J. Pharmacol. 2013, 45(1):80.
24. Nosbaum A., et al. Prevention of nonsteroidal inflammatory drug-induced urticaria and/or angioedema. Ann. Allergy Asthma Immunol. 2013, 110(4):263-266.
25. Pierce W.A., et al. Angioedema associated with dihydropyridine calcium-channel blockers in a child with Burkitt lymphoma. Am. J. Health Syst. Pharm. 2011, 68(5):402-406.
26. Rungravi Temsiririrkkul green drug Thai traditional medicine available for adult and children. accessed 5.3.2014. http://www.pharmacy.mahidol.ac.th/thai/knowledgeinfo.php?id=156.
27. Southward J., et al. Probable amlodipine-induced angioedema. Ann. Pharmacother. 2009, 43(4):772-776.
28. Stafford R.J., et al. Population-attributable risk estimates for risk factors associated with Campylobacter infection, Australia. Emerg. Infect. Dis. 2008, 14(6):895-901.
29. Stickel F., Schuppan D. Herbal medicine in the treatment of liver diseases. Dig. Liver Dis. 2007, 39(4):293-304.
30. Tassaneeyakul W., et al. Strong association between HLA-B*5801 and allopurinol-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in a Thai population. Pharmacogenet. Genomics. 2009, 19(9):704-709.
31. Techapornroong M., et al. Anaphylaxis: a ten years inpatient retrospective study. Asian Pac. J. Allergy Immunol. 2010, 28(4):262-269.
32. The Uppsala Monitoring Centre Glossary of terms used in Pharmacovigilance. accessed 30.4.2013a. http://who-umc.org/Graphics/24729.pdf.
33. The Uppsala Monitoring Centre The use of the WHO-UMC system for standardised case causality assessment http://who-umc.org/Graphics/24734.pdf Accessed 25.12.2013b.
34. The Uppsala Monitoring Centre Guideline for setting up and running a Pharmacovigilance Centre. accessed 10.1.2014. http://who-umc.org/graphics/24747.pdf.
35. van Puijenbroek E.P., et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol. Drug Saf. 2002, 11(1):3-10.
36. van Puijenbroek E.P., et al. Different risks for NSAID-induced anaphylaxis. Ann. Pharmacother. 2002, 36(1):24-29.
37. Walji R., et al. Consumers of natural health products: natural-born pharmacovigilantes?. BMC Complement. Altern. Med. 2010, 10:8.
38. Walji R., et al. Reporting natural health product related adverse drug reactions: is it the pharmacist's responsibility?. Int. J. Pharm. Pract. 2011, 19(6):383-391.
39. Wanat K.A., et al. Seasonal variation of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with trimethoprim-sulfamethoxazole. J. Am. Acad. Dermatol. 2009, 60(4):589-594.
40. Weismann K., et al. Bullous erythema multiforme following herpes zoster and varicella-zoster virus infection. J. Eur. Acad. Dermatol. Venereol. 1998, 11(2):147-150.
41. Zhang A.L., et al. A population survey on the use of 24 common medicinal herbs in Australia. Pharmacoepidemiol. Drug Saf. 2008, 17(10):1006-1013.