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What Fluoroquinolones Have the Highest Risk of Aortic Aneurysm? A Case/Non-case Study in VigiBase®

  • Agnès Sommet
  • Justine Bénévent
  • Vanessa Rousseau
  • Leila Chebane
  • Antonios Douros
  • Jean-Louis Montastruc
  • François MontastrucEmail author
Concise Research Reports

INTRODUCTION

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

METHODS

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 WORDS

fluoroquinolones levofloxacin aortic aneurysms aortic dissection 

Notes

Acknowledgments

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).

Funding/Support

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.

Author Contributions

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.

References

  1. 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
  2. 2.
    Lee CC, Lee MT, Chen YS, Lee SH, Chen YS, Chen SC, Chang SC. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA Intern Med. 2015; 175: 1839–47CrossRefGoogle Scholar
  3. 3.
    Pasternak B, Inghammar M, Svanström H. Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study. BMJ 2018; 360:k678. doi:  https://doi.org/10.1136/bmj.k678 CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Montastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011;72(6):905–8CrossRefGoogle Scholar
  5. 5.
    Pierfitte C, Bégaud B, Lagnaoui R, Moore ND. Is reporting rate a good predictor of risks associated with drugs? Br J Clin Pharmacol 1999; 47: 329–31CrossRefGoogle Scholar

Copyright information

© Society of General Internal Medicine 2018

Authors and Affiliations

  • Agnès Sommet
    • 1
  • Justine Bénévent
    • 1
  • Vanessa Rousseau
    • 1
  • Leila Chebane
    • 1
  • Antonios Douros
    • 2
    • 3
    • 4
  • Jean-Louis Montastruc
    • 1
  • François Montastruc
    • 1
    • 2
    Email author
  1. 1.Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, INSERM UMR 1027, CIC 1426Toulouse University Hospital, Faculty of Medicine, University of ToulouseToulouseFrance
  2. 2.Centre for Clinical Epidemiology, Lady Davis InstituteJewish General HospitalMontréalCanada
  3. 3.Department of Epidemiology, Biostatistics, and Occupational HealthMcGill UniversityMontréalCanada
  4. 4.Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Clinical Pharmacology and ToxicologyBerlinGermany

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