PMID- 20074608
OWN - NLM
STAT- MEDLINE
DCOM- 20100723
LR  - 20100421
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 57
IP  - 1
DP  - 2010 Jun
TI  - The state of adverse event reporting and signal generation of dietary supplements 
      in Korea.
PG  - 74-7
LID - 10.1016/j.yrtph.2009.12.011 [doi]
AB  - 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.
CI  - (c) 2010 Elsevier Inc. All rights reserved.
FAU - Park, Kyoung Sik
AU  - Park KS
AD  - The Nutrition & Functional Food Research Team, Korea Food & Drug Administration, 
      Seoul, Republic of Korea.
FAU - Kwon, Oran
AU  - Kwon O
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100113
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems/statistics & numerical data
MH  - Algorithms
MH  - *Databases, Factual
MH  - Dietary Supplements/*adverse effects/standards
MH  - Product Surveillance, Postmarketing/*methods/statistics & numerical data
MH  - Republic of Korea
EDAT- 2010/01/16 06:00
MHDA- 2010/07/24 06:00
CRDT- 2010/01/16 06:00
PHST- 2009/11/25 00:00 [received]
PHST- 2009/12/30 00:00 [revised]
PHST- 2009/12/31 00:00 [accepted]
PHST- 2010/01/16 06:00 [entrez]
PHST- 2010/01/16 06:00 [pubmed]
PHST- 2010/07/24 06:00 [medline]
AID - S0273-2300(10)00003-6 [pii]
AID - 10.1016/j.yrtph.2009.12.011 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2010 Jun;57(1):74-7. doi: 10.1016/j.yrtph.2009.12.011. 
      Epub 2010 Jan 13.