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KMID : 1011320090020010045
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Journal of Pharmacoepidemiology and Risk Management
2009 Volume.2 No. 1 p.45 ~ p.51
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Patterns of Suspected Adverse Events with Health Functional Foods and Diversity of Reported Terms
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Shin Ju-Young
Choi Nam-Kyong
Park Byung-Joo
Jung Sun-Young
Lee Jin-Ho
Kim Ye-Jee
Seong Jong-Mi
Kim Mi-Sook
Ahn So-Hyeon
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Abstract
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Objective: To describe the characteristics of the reports and the reporting patterns in the Korea health functional
food adverse event (AE) reporting data from 2006 to 2008.
Methods: This study was conducted to analyze the data based on spontaneously reported AEs with health functional foods between January 2006 and March 2008 to the Korea Food and Drug Administration. We recoded and categorized symptoms into medical terms based on consumer’s AEs narratives and described consumer’s diverse description. Each recoded AEs were translated to World Health Organization Adverse Reaction Terminology (WHO-ART). Distribution of system-organ classes and individual AEs were analyzed.
Results: The total number of AE reports with health functional foods was 1,045 based on cases and 1,618 based on AEs from Jan, 2006-Mar, 2008. The half of reported cases had multiple AEs and most AEs were clinical symptoms. The number of coded AEs was 358 according to the medical terms and 201 terms according to the WHO-ART code. By the application of code, one medical term had 4.5 ways and one WHO-ART code had 8.0 ways when reporter described one’s symptoms on AE experience. The medical terms such as epigastric discomfort, nausea, pruritus, rash had more than 10 ways of expression on symptoms. The most frequently reported system-organ class was gastro-intestinal system 794 (49.4%).
Conclusion: Most of health functional food spontaneous AE reports were provided in nonstandardized format and consumer’s narratives were very diverse. Overall patterns of health functional food AEs was similar with those of pharmaceutical drugs. The guidelines for the application of WHO-ART from reported AEs should be developed for the high quality of AEs data.
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KEYWORD
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Health functional food, Spontaneous adverse event reporting system, Adverse event, Adverse drug reaction, Reporting pattern, WHO-ART
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