Systemic quinolones and risk of acute liver failure I: Analysis of data from the US FDA adverse event reporting system

Background and Aim Quinolones are a potent and globally popular group of antibiotics that are used to treat a wide range of infections. Some case reports have raised concern about their possible association with acute hepatic failure (AHF). Data from the US FDA Adverse Event Reporting System were evaluated for signals of AHF in association with systemically administered quinolone antibiotics. Methods AHF reports between 1969 and 2019q2, with a focus on 2010–2019q2, were analyzed. Specifically, AHF reports linked to non‐quinolone antibiotics of known hepatotoxicity were compared to reports with non‐quinolone, non‐hepatotoxic (reference) antibiotics; and AHF reports with quinolones were also compared to reports with the same group of reference antibiotics. Two disproportionality signal detection techniques (proportional reporting ratio, PRR, and empirical Bayes geometric mean, EBGM) were used to assess the AHF signal for both analyses. Results Only ciprofloxacin showed a marginal and significant AHF signal (PRR: 1.85 [1.21, 2.81]; EBGM: 1.54 [1.06, 1.81]); moxifloxacin, levofloxacin, and ofloxacin showed weak and nonsignificant signals. Conclusion Further pharmacovigilance studies are required to confirm the association between ciprofloxacin and AHF seen in the present analysis. Concerns have been raised about a possible association between quinolone and acute hepatic failure (AHF). Analysis of reports of AHF in the US FDA Adverse Events Reporting System database identified a possible safety signal for ciprofloxacin. AHF reports were most frequently reported in women, those younger than 10 years of age, and those older than 90 years of age.