Disproportionality Analysis of Fluoroquinolone-Associated Peripheral Neuropathy in the FAERS Database (2007-2024)

Area of Science:

• Pharmacovigilance
• Drug Safety
• Neuroscience

Background:

• Fluoroquinolones (FQs) are widely used antibiotics.
• Regulatory bodies have identified risks of persistent adverse effects, including peripheral neuropathy (PN).
• A comprehensive assessment of PN-related adverse events (AEs) for all FDA-approved FQs is lacking.

Purpose of the Study:

• To conduct a pharmacovigilance assessment of PN-related AEs associated with six FDA-approved FQs.
• To identify potential safety signals for PN using disproportionality analysis in the FDA Adverse Event Reporting System (FAERS).

Main Methods:

• Analysis of AERs from the FAERS Public Dashboard (2007-2024 Q3) for six FQs.
• Disproportionality analysis following READUS-PV guidelines to detect PN-related safety signals.
• Exclusion of cases with non-FQ concomitant medications to isolate FQ effects.

Main Results:

• Positive disproportionality signals for PN-related AEs were found for ciprofloxacin, levofloxacin, moxifloxacin, and ofloxacin.
• PN-related safety signals were identified for gemifloxacin, indicating potential neurotoxicity.
• Women and younger adults (18-64) were more often in PN-related AERs, while older adults (≥65) and men were disproportionately represented in fatal outcomes.
• Combination FQ therapy showed higher disproportionality signals than monotherapy.

Conclusions:

• The study identified significant safety signals for peripheral neuropathy associated with multiple fluoroquinolones.
• Increased clinical vigilance and monitoring for early PN signs are recommended, especially when FQ use is necessary.
• Further research is needed to validate findings, identify at-risk populations, and develop neuroprotective strategies.