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

• Published in: Journal of Korean medical science Vol. 31; no. 9; pp. 1355 - 1361
• Main Authors: Soukavong, Mick, Kim, Jungmee, Park, Kyounghoon, Yang, Bo Ram, Lee, Joongyub, Jin, Xue-Mei, Park, Byung-Joo
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Academy of Medical Sciences 01.09.2016; 대한의학회
• Subjects: Amoxicillin - adverse effects; Anti-Bacterial Agents - adverse effects; Bayes Theorem; Data Mining; Databases, Factual; Humans; Odds Ratio; Original; Pharmacovigilance; Republic of Korea; 의학일반; Data Mining; KAERS Database; Pharmacovigilance; Adverse Event; Amoxicillin; Patient Safety
• ISSN: 1011-8934; 1598-6357; 1598-6357
• DOI: 10.3346/jkms.2016.31.9.1355

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.