Signal detection and clarification of peripheral neuropathy and Guillain-Barré syndrome associated with exposure to syst...

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Material Information

Title:
Signal detection and clarification of peripheral neuropathy and Guillain-Barré syndrome associated with exposure to systemic fluoroquinolones
Series Title:
Ali AK. Signal detection and clarification of peripheral neuropathy and Guillain-Barré syndrome associated with exposure to systemic fluoroquinolones. British Journal of Pharmaceutical Research. April 2014; 4(4):407-417.
Physical Description:
Journal Article
Creator:
Ayad Ali
Publisher:
Science Domain
Place of Publication:
United Kingdom
Publication Date:

Notes

Abstract:
Aims: Peripheral neuropathy (PN) is an identified risk of systemic antibacterial therapy with fluoroquinolones. The risk and its severity, including the development of Guillain-Barré syndrome (GBS) between individual agents is uncertain. This study examines the association between fluoroquinolones and PN and GBS in cases spontaneously reported to the FDA Adverse Event Reporting System (FAERS). Study Design: Retrospective pharmacovigilance analysis. Place and Duration of Study: Cases submitted to FAERS between 1997 and 2012. Methodology: The MedDRA Preferred Term was used to define PN and GBS. Individual fluoroquinolones were identified by generic names and route of administration. Empirical Bayes Geometric Mean (EBGM) with 95% confidence interval (EB05-EB95) was calculated as disproportionality measure. Safety signals with EB05>2 was considered a significant disproportional increase in event reporting of at least twice times higher than expected. Results: There were 539 PN reports out of 46,257 adverse event reports submitted for fluoroquinolones. 9% of PN reports were for GBS. Significant disproportionality of PN (EBGM 2.70; EB05-EB95 2.51-2.90) and GBS (EBGM 3.22; EB05-EB95 2.55-4.02) was identified for fluoroquinolones. Signals of PN were detected for ciprofloxacin (EBGM 3.24; EB05-EB95 2.87-3.66) and levofloxacin (EBGM 3.36; EB05-EB95 3.02-3.72). A GBS signal was detected for ciprofloxacin (EBGM 4.15; EB05-EB95 2.94-5.74). GBS and PN respectively ranked 6th and 8th among reported neurological events. Conclusion: This study reemphasizes the link between fluoroquinolones and PN, and shows potential association with more severe forms of nerve damage, e.g. GBS. Unless the benefit of fluoroquinolone therapy outweighs PN risk, treatment with alternative antibacterial agents is recommended.
Acquisition:
Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Ayad Ali.
Publication Status:
Published

Record Information

Source Institution:
University of Florida Institutional Repository
Holding Location:
University of Florida
Rights Management:
All rights reserved by the source institution.
System ID:
IR00003621:00001