J Korean Med Sci.  2016 Sep;31(9):1355-1361. 10.3346/jkms.2016.31.9.1355.

Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database

• Soukavong
• Kim J
• Park K
• Yang BR
• Lee J
• Jin XM
• Park BJ

• KMID: 2468266
• DOI: http://doi.org/10.3346/jkms.2016.31.9.1355

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.

Keyword

KAERS Database; Amoxicillin; Adverse Event; Data Mining; Pharmacovigilance; Patient Safety

MeSH Terms

Amoxicillin/*adverse effects
Anti-Bacterial Agents/*adverse effects
Bayes Theorem
Data Mining
*Databases, Factual
Humans
Odds Ratio
Pharmacovigilance
Republic of Korea
Anti-Bacterial Agents
Amoxicillin

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