Long Meng1, Jing Huang2, Yuntao Jia3, Huali Huang1, Feng Qiu1, Shusen Sun4,5,6. 1. Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. 2. Department of Respiratory, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. 3. Department of Pharmacy, Ministry of Education Key Laboratory of Child Development and Disorders, International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China. 4. Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Western New England University, Springfield, Massachusetts. 5. Department of Pharmacy, Xiangya Hospital Central South University, Changsha, Hunan, China. 6. Institute for Rational and Safe Medication Practices, National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Abstract
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.
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.
Authors: Mohamed Kadry Taher; Abdallah Alami; Christopher A Gravel; Derek Tsui; Lise M Bjerre; Franco Momoli; Donald R Mattison; Daniel Krewski Journal: JGH Open Date: 2021-06-04