Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database
| Autor: | Byung Joo Park, Mick Soukavong, Joongyub Lee, Bo Ram Yang, Xue Mei Jin, Kyounghoon Park, Jungmee Kim |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
KAERS Database
Databases Factual 030204 cardiovascular system & hematology computer.software_genre 03 medical and health sciences Adverse Event Reporting System Pharmacovigilance 0302 clinical medicine Republic of Korea medicine Odds Ratio Data Mining Humans 030212 general & internal medicine Sinusitis Adverse effect Database Adverse Event business.industry Amoxicillin Bayes Theorem General Medicine Odds ratio Pharmacology Drug Therapy & Toxicology medicine.disease Anti-Bacterial Agents Bronchitis Original Article Patient Safety business computer Adverse drug reaction medicine.drug |
| Zdroj: | Journal of Korean Medical Science |
| ISSN: | 1598-6357 1011-8934 |
| Popis: | 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. Graphical Abstract |
| Databáze: | OpenAIRE |
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