Signal Detection and Clarification of Peripheral Neuropathy and Guillain-Barré Syndrome Associated with Exposure to Systemic Fluoroquinolones
Journal Title: Journal of Pharmaceutical Research International - Year 2014, Vol 4, Issue 4
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.
Authors and Affiliations
Ayad K. Ali
Keywords
Related Articles
- EP ID EP344673
- DOI 10.9734/BJPR/2014/6954
- Views 99
- Downloads 0
Lubricating Properties of Co-processed Coconut Oil in Paracetamol Tablets Formulation
Objective: Lubricants are additives which reduce friction and so essential components of drug formulation. This piece of work was initiated to evaluate coconut oil as a co-processed lubricant in the formulation and compr...
Antibiotic Resistance: Challenges and Prospect for Therapy in Developing Countries
The hope raised by the discovery of antibiotics has been marred by the emergence of antibiotic resistance. The major reason for this is the inappropriate use of antibiotics due to a lack of uniform policy and disregard t...
An Observational Prospective Study on Prevalence and Monitoring of Adverse Drug Reactions in Tertiary Care Teaching Hospital
Objective: To study the prevalence of ADRs in the in-patient departments of General Medicine, Pediatrics, Dermatology at tertiary care hospital. Materials and Methods: An Observational Prospective Study was designed from...
Phytochemical Testing and In vitro Antibacterial Activity of Bixa orellana (Annatto) Seed Extract
Aim: The present study was designed to investigate the antibacterial activity of the seeds of Bixa orellana (Annatto, family Bixaceae) extracts. Methods: Powdered seed material was extracted using either organic solvents...
Synthesis, Characterization and Evaluation of Biological Properties of Pyrazolo- and Oxazolo-pyridocarbazoles and Pyridoazacarbazoles as Potent Anti-microbial Agents
Aims: Fused carbazoles, azacarbazoles and quinolines are endowed with a wide array of pharmacological properties. Keeping these properties in the mind, the study was undertaken to seek structural modifications to generat...