PMID- 27510377
OWN - NLM
STAT- MEDLINE
DCOM- 20170713
LR  - 20220331
IS  - 1598-6357 (Electronic)
IS  - 1011-8934 (Print)
IS  - 1011-8934 (Linking)
VI  - 31
IP  - 9
DP  - 2016 Sep
TI  - Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse 
      Event Reporting System Database.
PG  - 1355-61
LID - 10.3346/jkms.2016.31.9.1355 [doi]
AB  - We conducted pharmacovigilance data mining for a beta-lactam antibiotics, 
      amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 
      countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and 
      Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a 
      nationwide database of AE reports, between December 1988 and June 2014. 
      Frequentist and Bayesian methods were used to calculate disproportionality 
      distribution of drug-AE pairs. The AE which was detected by all the three indices 
      of proportional reporting ratio (PRR), reporting odds ratio (ROR), and 
      information component (IC) was defined as a signal. The KAERS database contained 
      a total of 807,582 AE reports, among which 1,722 reports were attributed to 
      amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE 
      pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin 
      signals. Comparing the drug labels of 9 countries, 12 adverse events including 
      ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, 
      gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal 
      crying, induration, pulmonary carcinoma, and influenza-like symptoms were not 
      listed on any of the labels of nine countries. In conclusion, we detected 12 new 
      signals of amoxicillin which were not listed on the labels of 9 countries. 
      Therefore, it should be followed by signal evaluation including causal 
      association, clinical significance, and preventability.
FAU - Soukavong, Mick
AU  - Soukavong M
AUID- ORCID: 0000-0003-2958-7936
AD  - Department of Preventive Medicine, Seoul National University College of Medicine, 
      Seoul, Korea.
FAU - Kim, Jungmee
AU  - Kim J
AUID- ORCID: 0000-0002-1955-843X
AD  - Department of Preventive Medicine, Seoul National University College of Medicine, 
      Seoul, Korea.
FAU - Park, Kyounghoon
AU  - Park K
AUID- ORCID: 0000-0001-5800-917X
AD  - Department of Preventive Medicine, Seoul National University College of Medicine, 
      Seoul, Korea.
FAU - Yang, Bo Ram
AU  - Yang BR
AUID- ORCID: 0000-0002-8771-8829
AD  - Medical Research Collaborating Center, Seoul National University Hospital and 
      Seoul National University College of Medicine, Seoul, Korea.
FAU - Lee, Joongyub
AU  - Lee J
AUID- ORCID: 0000-0003-2784-3772
AD  - Medical Research Collaborating Center, Seoul National University Hospital and 
      Seoul National University College of Medicine, Seoul, Korea.
FAU - Jin, Xue Mei
AU  - Jin XM
AUID- ORCID: 0000-0003-1132-7271
AD  - Department of Preventive Medicine, Seoul National University College of Medicine, 
      Seoul, Korea.
FAU - Park, Byung Joo
AU  - Park BJ
AUID- ORCID: 0000-0003-4630-4942
AD  - Department of Preventive Medicine, Seoul National University College of Medicine, 
      Seoul, Korea. bjpark@snu.ac.kr.
LA  - eng
PT  - Journal Article
PL  - Korea (South)
TA  - J Korean Med Sci
JT  - Journal of Korean medical science
JID - 8703518
RN  - 0 (Anti-Bacterial Agents)
RN  - 804826J2HU (Amoxicillin)
SB  - IM
MH  - Amoxicillin/*adverse effects
MH  - Anti-Bacterial Agents/*adverse effects
MH  - Bayes Theorem
MH  - Data Mining
MH  - *Databases, Factual
MH  - Humans
MH  - Odds Ratio
MH  - Pharmacovigilance
MH  - Republic of Korea
PMC - PMC4974175
OTO - NOTNLM
OT  - Adverse Event
OT  - Amoxicillin
OT  - Data Mining
OT  - KAERS Database
OT  - Patient Safety
OT  - Pharmacovigilance
COIS- DISCLOSURE: The authors have no conflicts of interest to disclose.
EDAT- 2016/08/12 06:00
MHDA- 2017/07/14 06:00
PMCR- 2016/09/01
CRDT- 2016/08/12 06:00
PHST- 2015/12/24 00:00 [received]
PHST- 2016/05/29 00:00 [accepted]
PHST- 2016/08/12 06:00 [entrez]
PHST- 2016/08/12 06:00 [pubmed]
PHST- 2017/07/14 06:00 [medline]
PHST- 2016/09/01 00:00 [pmc-release]
AID - 31.1355 [pii]
AID - 10.3346/jkms.2016.31.9.1355 [doi]
PST - ppublish
SO  - J Korean Med Sci. 2016 Sep;31(9):1355-61. doi: 10.3346/jkms.2016.31.9.1355.