Zeitschrift für klinische Toxikologie
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Abstrakt

Adverse Events and Signal Generation Induced by the Use of Quinolone Vs Cephalosporin: A Nationwide Spontaneous Adverse Event Reporting Database, 2005-2017

Dongmun Ha, Hye-min Yu, Ju-Young Shin

Objective: Quinolones are one of the most commonly prescribed classes of antibacterial in the world. We comparatively analysed the status of adverse events (AE) due to quinolones with respect to the use of cephalosporins and detected signals for quinolones. Methods: We used data from the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD), collected between 2005 and 2017. Differences in patient demographics, report type, reporter, causality, and serious-AEs between quinolones and cephalosporins was compared, the annual frequency ratio of quinolone AEs versus cephalosporin AEs were compared. Metrics including proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC), used to detect signals for quinolones, and they were compared with the information on the drug labels in the USA, EU, and Korea. Results: The total number of AE reported for quinolones and cephalosporins was 22,352 and 76,325, respectively. Both drugs were most used in patients over 60 years of age, and this tendency was more pronounced for quinolones [proportion of patients over 60 years of age: quinolones 45.62% (10,196) vs. cephalosporins 32.85% (25,074)]. The frequency ratio of quinolone AEs to cephalosporin AEs (quinolone AEs/cephalosporin AEs) increased gradually over the years from 2008 (0.11) to 2016 (0.32). The frequency of quinolone AEs was higher than that of cephalosporins in disorders of the skin and appendages only. Thirty-seven cases (10.0%) for quinolones were confirmed as signal information from a total of 369 drug-AE pairs. The number of signals satisfied all three methods (PRR, ROR, and IC) were 23 of 37. Total 9 cases (abscess, leg pain, vein pain, cachexia, skin discoloration, hyperventilation, stomatitis ulcerative, photopsia, and cardiac enzymes increased) out of 37 signals were identified as new signals that were not present on either the Korea, USA, or EU labels. Conclusion: Newly detected signals for quinolones should be continuously monitored to assess causality.