Incidence, clinical features, and risk factors of fluoroquinolone-induced acute liver injury: a case-control study

Abstract

Background

Fluoroquinolone-related hepatotoxicity is rare but serious and is attracting increasing attention. We explored the incidence, clinical features and risk factors of acute liver injury associated with fluoroquinolone use.

Materials and methods

Based on the Adverse Drug Events Active Surveillance and Assessment System that we developed, we carried out a case-control study by enrolling patients who were hospitalized and received fluoroquinolones to treat or prevent infections at the Chinese People’s Liberation Army General Hospital from Jan 2016 to Dec 2017. The incidence of fluoroquinolone-induced acute liver injury was estimated, and logistic regression was used to reveal the risk factors of this adverse reaction.

Results

We found that 17,822 patients received fluoroquinolones, and 13,678 of them met the inclusion criteria. A total of 91 patients developed acute liver injury after receiving the medication, and 369 controls were matched to these patients. The overall incidence of fluoroquinolone-induced acute liver injury in the Chinese population is approximately 6–7 cases per 1,000 individuals annually. Multivariate logistic regression analysis showed that older age slightly decreased the risk of hepatotoxicity (OR, 0.98; 95% CI, 0.96–0.99). The male sex (OR, 2.19; 95% CI, 1.07–4.48), alcohol abuse (OR, 2.91; 95% CI, 1.39–6.11) and hepatitis B carrier status (OR, 2.38; 95% CI, 1.04–5.48) increased the risk of liver injury. Concurrent use of cephalosporins or carbapenems was also associated with an increased risk.

Conclusion

Increased risk of fluoroquinolone-related hepatotoxicity may be associated with youth, the male sex, alcohol abuse, hepatitis B carrier status and the concurrent use of cephalosporins or carbapenems.

Keywords:

• fluoroquinolones
• drug-induced liver injury
• incidence
• risk factors
• pharmacovigilance

Acknowledgments

This study was supported by the National Natural Science Foundation of China (Grant No. 81773825). The funding body had no role in the study design, data collection, data analysis, interpretation, or manuscript writing.

Disclosure

The authors report no conflicts of interest in this work.