Document Detail


Safety of herbal products in Thailand: an analysis of reports in the thai health product vigilance center database from 2000 to 2008.
MedLine Citation:
PMID:  21417506     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The use of herbal products continues to expand rapidly across the world and concerns regarding the safety of these products have been raised. In Thailand, Thai Vigibase, developed by the Health Product Vigilance Center (HPVC) under the Thai Food and Drug Administration, is the national database that collates reports from health product surveillance systems and programmes. Thai Vigibase can be used to identify signals of adverse events in patients receiving herbal products.
OBJECTIVES: The purpose of the study was to describe the characteristics of reported adverse events in patients receiving herbal products in Thailand.
METHODS: Thai Vigibase data from February 2000 to December 2008 involving adverse events reported in association with herbal products were used. This database includes case reports submitted through the spontaneous reporting system and intensive monitoring programmes. Under the spontaneous reporting system, adverse event reports are collected nationwide via a national network of 22 regional centres covering more than 800 public and private hospitals, and health service centres. An intensive monitoring programme was also conducted to monitor the five single herbal products listed in the Thai National List of Essential Medicines (NLEM), while another intensive monitoring programme was developed to monitor the four single herbal products that were under consideration for inclusion in the NLEM. The database contained patient demographics, adverse events associated with herbal products, and details on seriousness, causality and quality of reports. Descriptive statistics were used for data analyses.
RESULTS: A total of 593 reports with 1868 adverse events involving 24 different products were made during the study period. The age range of individuals was 1-86 years (mean 47 years). Most case reports were obtained from the intensive monitoring programme. Of the reports, 72% involved females. The herbal products for which adverse events were frequently reported were products containing turmeric (44%), followed by andrographis (10%), veld grape (10%), pennywort (7%), plai (6%), jewel vine (6%), bitter melon (5%) and snake plant (5%). Gastrointestinal problems were the most common adverse effect reported. Serious adverse events included Stevens-Johnson syndrome, anaphylactic shock and exfoliative dermatitis.
CONCLUSIONS: Adverse event reports on herbals products were diverse, with most of them being reported through intensive monitoring programmes. Thai Vigibase is a potentially effective data source for signal detection of adverse events associated with herbal products.
Authors:
Surasak Saokaew; Wimon Suwankesawong; Unchalee Permsuwan; Nathorn Chaiyakunapruk
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Drug safety     Volume:  34     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-03-22     Completed Date:  2011-07-11     Revised Date:  2014-11-17    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  339-50     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Adverse Drug Reaction Reporting Systems* / statistics & numerical data
Aged
Aged, 80 and over
Child
Child, Preschool
Data Interpretation, Statistical
Databases, Factual* / statistics & numerical data
Drug-Related Side Effects and Adverse Reactions* / epidemiology,  etiology
Female
Humans
Infant
Male
Middle Aged
Plant Preparations / adverse effects*,  standards
Retrospective Studies
Thailand
Young Adult
Chemical
Reg. No./Substance:
0/Plant Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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