Association Between Oral Fluoroquinolones and Neuropsychiatric Events: Self-Controlled Case Series With Active
Yin Zhang1, Min Fan2, Natalie T Y Tsie3
1Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Pharmacoepidemiology and Drug Safety
|October 18, 2024
Summary
This study found that while fluoroquinolone use was linked to a temporary increase in neuropsychiatric events, this pattern was also seen with amoxicillin/clavulanic acid. Adjusted analyses showed no significant difference in risk between the two, suggesting neuropsychiatric events may not be a deciding factor in prescribing these antibiotics.
Area of Science:
- Pharmacovigilance
- Neuroscience
- Clinical Epidemiology
Background:
- Evidence on neuropsychiatric effects of fluoroquinolones is primarily from case reports.
- Population-based data on fluoroquinolone-associated neuropsychiatric events are limited.
Purpose of the Study:
- To investigate the association between fluoroquinolone use and acute neuropsychiatric events.
- To utilize a self-controlled case series (SCCS) with an active comparator to minimize confounding.
Main Methods:
- A self-controlled case series with an active comparator design was employed.
- Data from Hong Kong public healthcare records (2001-2013) were analyzed.
- Incidence rate ratios (IRR) for neuropsychiatric events were compared before and after fluoroquinolone exposure, using amoxicillin/clavulanic acid as a comparator.
Main Results:
- An increased risk of neuropsychiatric events was observed during fluoroquinolone use (IRR: 2.11) and up to 7 days post-prescription (IRR: 1.90).
- A similar pattern was noted for amoxicillin/clavulanic acid users (IRR: 1.92 and 1.81, respectively).
- Comparator-adjusted analyses revealed no significant difference in neuropsychiatric event risk between fluoroquinolones and amoxicillin/clavulanic acid (adjusted IRR: 1.10 and 1.05).
Conclusions:
- While initial analysis showed a temporal association between fluoroquinolones and neuropsychiatric events, the similar pattern with amoxicillin/clavulanic acid suggests this may not be drug-specific.
- Adjusted risk estimates indicate no significant difference in neuropsychiatric event risk between fluoroquinolones and amoxicillin/clavulanic acid.
- The findings suggest that the risk of neuropsychiatric events should not be a primary factor in choosing between these antibiotic classes.
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