Assessing fluoroquinolone‐associated aortic aneurysm and dissection: Data mining of the public version of the FDA adverse event reporting system

Abstract

Summary Aims A recent large epidemiological study found fluoroquinolone use is associated with an increased risk of aortic aneurysm or dissection. We aimed to examine fluoroquinolone (ciprofloxacin, levofloxacin and moxifloxacin) associated aortic aneurysm or dissection through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods Reports to the FAERS from 1 January 2004 to 31 December 2016 were analysed. Pharmacovigilance tools were used for quantitative detection of signals that is, drug‐associated adverse events, including reporting odds ratio, proportional reporting ratio, information component given by a Bayesian confidence propagation neural network and empirical Bayes geometric mean. Sensitivity analyses that limited the data by gender and adverse event date also showed similar trends. Results Based on 3721 adverse event reports, all three fluoroquinolones are associated with aortic aneurysm, and levofloxacin is associated with aortic dissection. The risk of aortic aneurysm is higher than the aortic dissection. Oral administration of fluoroquinolones is more likely to produce these adverse events. Conclusion The results obtained herein are consistent with clinical observations, suggesting the necessity for further clinical research on aortic aneurysm and dissection associated with fluoroquinolones.

A Pharmacovigilance Study of Hydroxychloroquine Cardiac Safety Profile: Potential Implication in COVID-19 Mitigation

“…This study involves data queries between May 29, 1998 (FDA approval) [ 21 ] to December 31, 2019, for HCQ. We adopted the validated pharmacovigilance tool [ 22 , 23 , 24 ], OpenVigil (version 2.1), to query FAERS database [ 25 , 26 ]. OpenVigil 2.1 has been designed for complete case analysis and is superior for analyses of disproportionality, as it uses cleaned FDA data by removing duplicates and incomplete reports [ 25 ].…”

“…This is supported by the CloroCOVID-19 study in which patients got fatal arrhythmias very quickly, even much more than one would expect from the data presented herein. The CV-AE risk prediction by disproportionality analysis with the FAERS pharmacovigilance database has been demonstrated in various studies [ 22 , 23 , 24 ], but it is of paramount importance that hypotheses generated using the pharmacovigilance database analysis should be validated by prospective studies. The significance of current research is that it will inform clinicians about CV-AEs related to HCQ treatment in a timely manner, which will be highly useful to select the ideal treatment agent for the individual patient suffering from COVID-19.…”

Relationship between fluoroquinolones and the risk of aortic diseases: a meta-analysis of observational studies

“…Another study suggested that patients with aortic aneurysm, aortic dissection or Marfan syndrome had a higher risk for aortic rupture when exposed to fluoroquinolones [27]. Moreover, compared with intravenous fluoroquinolones, oral fluoroquinolones carried a higher risk of negative effects, and levofloxacin was associated with not only aortic aneurysm but also aortic dissection [28]. Based on these findings, future studies should focus on age stratification, the evaluation of individuals' fluoroquinolone with regard to the risk of aortic aneurysm or dissection and different exposure times, which may provide additional information because aortic diseases are rare adverse events that cannot be studied in randomized controlled trials.…”

Relationship between fluoroquinolones and the risk of aortic diseases: a meta-analysis of observational studies

“…[27] Moreover, compared with intravenous fluoroquinolones, oral fluoroquinolones carried a higher risk of negative effects, and levofloxacin was associated with not only aortic aneurysm but also aortic dissection. [28] Based on these findings, future studies should focus on age stratification, the evaluation of individuals' fluoroquinolone with regard to the risk of aortic aneurysm or dissection and different exposure times, which may provide additional information because aortic diseases are rare adverse events that cannot be studied in randomized controlled trials.…”