Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database
Journal of Korean Medical Science
;
: 1355-1361, 2016.
Article
in English
| WPRIM
| ID: wpr-34879
ABSTRACT
We conducted pharmacovigilance data mining for a β-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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Sinusitis
/
Bronchitis
/
Gastroesophageal Reflux
/
Odds Ratio
/
Rhinitis
/
Bayes Theorem
/
Crying
/
Drug-Related Side Effects and Adverse Reactions
/
Data Mining
/
Pharmacovigilance
Type of study:
Diagnostic study
/
Etiology study
/
Prognostic study
Country/Region as subject:
Asia
/
Europa
Language:
English
Journal:
Journal of Korean Medical Science
Year:
2016
Type:
Article
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