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 97
- Downloads 0
Antioxidant Activity, Total Phenolic and Flavonoid Contents of Essential Oils of Three Cyperus Species (Cyperaceae)
Aims: To determine the in vitro antioxidant activity, total phenolic and flavonoid contents of essential oils from the rhizomes of Cyperus distans, Cyperus papyrus and Cyperus rotundus collected from different locations....
Efficacy of Vitamin B6 on Pregnancy Outcomes: A Randomized Clinical Trial
Background: Postpartum depression is a common and disabling disorder. A low level of vitamin B6 might theoretically causes symptoms of depression. The aim of this study was to investigate the effect of vitamin B6 on Preg...
Acute and Sub-acute Oral Toxicity Study of Drepanoalpha® (A Poly-Herbal Formula Used in the Management of Sickle Cell Disease) in Guinea-pigs
Aims: To deepen the toxicological investigation of Drepanoalpha®, a poly-herbal formula used for its antisickling and radical scavenging properties in Congolese traditional medicine. Study Design: To evaluate lethality,...
Inhibition of α-amylase and α-glucosidase by Acanthus montanus Leaf Extracts
Aim: The aim of this study was to determine the in-vitro anti-diabetic potentials of Acanthus montanus. This was done by assessing the inhibitory effect of both methanol and ethylacetate extracts of the plant on the acti...
Antioxidant, Analgesic and Antipyretic Activities of Ethanol Extract of the Stem Bark Dichaetanthera africana (Hooker F.) Jacq. Felix. (Melastomataceae)
Aims: This study was designed to elucidate the antioxidant, analgesic and antipyretic activities of the ethanol extract of the stem bark of Dichaetanthera africana. Place and Duration of Study: Department of Pharmacogno...