A VigiBase Descriptive Study of Fluoroquinolone-Associated Peripheral Nervous System Disorders.

Madalina Huruba,Andreea Farcas,Daniel Corneliu Leucuta,Camelia Bucsa,Cristina Mogosan

doi:10.3390/ph15020143

Madalina Huruba, Andreea Farcas + Show 3 more

Open Access

https://doi.org/10.3390/ph15020143

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Abstract

Background: Recent drug safety concerns described fluoroquinolone (FQ)-induced peripheral nervous system reactions. The objective of this study was to characterize such reports from VigiBase. Methods: The analysis included FQ-induced peripheral nervous system disorder adverse drug reaction (ADR) reports (up to July 2019). We looked into the disproportionality data in terms of proportional reporting ratio (PRR) and information component (IC) values, and descriptive analysis was performed for FQ-ADRs positive associations (ADRs, suspected FQs, potential risk factors, such as associated therapy and underlying disease). Results: Disproportionality analysis revealed 4374 reports (3531 serious) with peripheral nervous system ADRs associated with at least three FQs (neuropathy peripheral, 5492; neuralgia, 481; polyneuropathy, 220; sensory loss, 99; peripheral sensorimotor neuropathy, 39). Among these, both time-to-onset and duration of reaction were mostly between 1–7 days and ≥30 days. Most of the ADRs were not recovered/resolved at the time of reporting. Conclusion: The results augment the existing data on FQ safety concerns, specifically their potential effect on the nervous system.

Highlights

Used for both prophylaxis and the therapy of various infections [1,2], due to their high antibacterial activity [1,3], broad spectra, and favorable pharmacokinetics [3], fluoroquinolones (FQs) are generally well tolerated [2,4,5,6], reportedly possessing a favorable safety profile [7]
We looked at adverse drug reaction (ADR) pertaining to peripheral neuropathy (PN) Standardized MedDRA Query (SMQ) [24], among which, only neuropathy peripheral, neuralgia, peripheral sensorimotor neuropathy, polyneuropathy, and sensory loss were the ones associated with at least three
VigiBase, a database maintained by the Uppsala Monitoring Centre (UMC), with more than 19 million individual case case safety safety reports (ICSRs) submitted by national PV centers up to May 2019, was used as the data source

Summary

Introduction

Used for both prophylaxis and the therapy of various infections [1,2], due to their high antibacterial activity [1,3], broad spectra (against respiratory, genitourinary, gastrointestinal, bone, and ophthalmic infections), and favorable pharmacokinetics [3], fluoroquinolones (FQs) are generally well tolerated [2,4,5,6], reportedly possessing a favorable safety profile [7]. Serious, disabling, and potentially permanent side effects associated with the class and affecting muscles, joints, and the nervous system, triggered safety reviews by both the U.S Food and Drug Administration (FDA) (2016) [8] and the European Medicines Agency (EMA) (2019) [9]. These resulted in restrictions of use and downgrade of (fluoro)quinolones from being the first-line antibacterial agents, with specific exceptions [10]. Methods: The analysis included FQ-induced peripheral nervous system disorder adverse drug reaction (ADR) reports (up to July 2019). Conclusion: The results augment the existing data on FQ safety concerns, their potential effect on the nervous system

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