Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.
10.3346/jkms.2016.31.9.1355
- Author:
Mick SOUKAVONG
1
;
Jungmee KIM
;
Kyounghoon PARK
;
Bo Ram YANG
;
Joongyub LEE
;
Xue Mei JIN
;
Byung Joo PARK
Author Information
1. Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea. bjpark@snu.ac.kr
- Publication Type:Original Article
- Keywords:
KAERS Database;
Amoxicillin;
Adverse Event;
Data Mining;
Pharmacovigilance;
Patient Safety
- MeSH:
Amoxicillin*;
Anti-Bacterial Agents;
Bayes Theorem;
Bronchitis;
Crying;
Data Mining;
Drug-Related Side Effects and Adverse Reactions*;
France;
Gastroesophageal Reflux;
Germany;
Hypercholesterolemia;
Italy;
Japan;
Korea*;
Laos;
Mouth;
Odds Ratio;
Patient Safety;
Pharmacovigilance;
Rhinitis;
Sinusitis
- From:Journal of Korean Medical Science
2016;31(9):1355-1361
- CountryRepublic of Korea
- Language:English
-
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.
