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The state of adverse event reporting and signal generation of dietary supplements in Korea

Title
The state of adverse event reporting and signal generation of dietary supplements in Korea
Authors
Park K.S.Kwon O.
Ewha Authors
권오란
SCOPUS Author ID
권오란scopus
Issue Date
2010
Journal Title
Regulatory Toxicology and Pharmacology
ISSN
0273-2300JCR Link
Citation
vol. 57, no. 1, pp. 74 - 77
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Since 2006, the Korea Food & Drug Administration (KFDA) has established an AE monitoring system for dietary supplements with emphases on the facilitation of AE reporting from consumers, the creation of a new database for aggregating information from multiple sources, and the proposition of appropriate tools for analyzing the likelihood that a product or an ingredient caused an adverse reaction. During the 3-year period from 2006 through 2008, 1430 AE reports had been collected from consumers and 222 AE reports providing complete case details were extracted by integrating AE reports into the product information. The 'relative AE profile' method was applied first to detect statistically significant signals, resulting in only one substrate-event pair (dietary fiber and vomiting) as a signal. Subsequently, the WHO scale was used to estimate the likelihood that dietary fiber caused vomiting. Due to the limited information available, the KFDA determined that no conclusion could be drawn to support any regulatory action, but that the relationship between dietary fiber and vomiting is an area of concern warranting further investigation. © 2010 Elsevier Inc.
DOI
10.1016/j.yrtph.2009.12.011
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신산업융합대학 > 식품영양학과 > Journal papers
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