J Pharmacoepidemiol Risk Manage.  2022 Mar;14(1):93-99. 10.56142/2022.14.1.93.

Analysis of Fluoroquinolone Adverse Drug Reaction Reported in a Single Center

• Kim HJ
• Hwang S
• Kim HH
• Jang JY
• Suh JH
• Kang DY
• Lee JY
• Kang HR

• KMID: 2534679
• DOI: http://doi.org/10.56142/2022.14.1.93

Abstract

Objective
With the increased use of fluoroquinolone in the clinical setting, adverse drug reactions (ADR) to fluoroquinolones are also on the rise. The purpose of this study was to analyze the prevalence of ADRs to fluoroquinolones according to type, severity, and pharmacological classification. In addition, we analyzed the prevalence of hypersensitivity reactions according to the R1 side chain of cephalosporins in patients with ADRs to both cephalosporins and fluoroquinolones.
Methods
This study included patients who received parenteral and oral cephalosporin or fluoroquinolone antibiotics from January, 2009 to July, 2021. Data on ADR were obtained from the spontaneous reporting system database of the Drug Safety Center at Seoul National University Hospital.
Results
A total of 132,624 patients received systemic fluoroquinolones, and the prevalence rate of ADRs was 1.7%. The prevalence rate of type A ADRs to levofloxacin was higher than that of the entire fluoroquinolone group (1.0% vs. 0.8%, p < 0.001). Gastrointestinal symptoms (41.8%) were most frequently reported type A ADR followed by skin reactions (11.5%). In the levofloxacin group, musculoskeletal, liver and biliary symptoms were more frequently reported in comparison to the entire fluoroquinolone group (p = 0.001 and 0.02, respectively). The prevalence rate of type B ADRs to moxifloxacin and gemifloxacin was higher compared to the entire fluoroquinolone group (1.8%, 1.6% respectively). A total of 167 patients reported ADRs to both cephalosporins and fluoroquinolones, and 30 patients (45.5%) showed cutaneous symptoms to both drugs. When classified according to the R1 side chain of cephalosporins, we found a significant correlation between hypersensitivity reactions to cefaclor, cephalexin, cephradine with levofloxacin and moxifloxacin.
Conclusion
In conclusion, the type and intensity of ADRs differ according to type of fluoroquinolone. Careful consideration is needed when choosing a fluoroquinolone in patients with a history of cephalosporin hypersensitivity.

Keyword

Fluoroquinolones; Drug-related side effects and adverse reactions; Cephalosporins