What Fluoroquinolones Have the Highest Risk of Aortic Aneurysm? A Case/Non-case Study in VigiBase®
Fluoroquinolones have a broad antimicrobial activity and are one of the most commonly prescribed groups of antibiotics. They are widely used for the treatment of many infections affecting among others the urinary, gastro-intestinal, abdominal, or respiratory tract. Recently, fluoroquinolones were associated with an increased risk of aortic aneurysms and dissections,1, 2, 3 with an excess risk of 0.5 cases per 1000 person-years for fluoroquinolone users versus amoxicillin users.3 However, these studies were underpowered to distinguish between different fluoroquinolones. Therefore, we assessed the specific risk of individual fluoroquinolones for aortic aneurysms and dissections, using the case/non-case design, a method validated to detect very rare events.4
The study was conducted using Vigibase®, the World Health Organization Global Individual Case Safety Reports (ICSRs) database which includes more than 16 million reports forwarded to the WHO Uppsala Monitoring...
KEY WORDSfluoroquinolones levofloxacin aortic aneurysms aortic dissection
The authors would like to thank the Uppsala Monitoring Centre (UMC) which provided and gave permission to use the data analyzed in the present study. The authors are indebted to the National Pharmacovigilance Centers that contributed data. The opinions and conclusions in this study are not necessarily those of the various centers or of the WHO or ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé, France). The access to the World Health Organization Global Individual Case Safety Report (ICSR) database, VigiBase® is available without fees in the department of the authors (Jean-Louis Montastruc, Vanessa Rousseau).
The work was performed during the university research time of the authors using the database which is available without fees in the department of the authors. There were no funding sources.
Dr. François Montastruc takes responsibility for the integrity of the data and the accuracy of the data analysis.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they do not have a conflict of interest.
- 1.Daneman N, Lu H, Redelmeier DA. Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study. BMJ Open 2015 18;5(11):e010077.Google Scholar