The Association Between the Use of Oral Fluoroquinolones and Neuropsychiatric Events: A Self‐Controlled Case Series Study

Abstract

Background: Oral fluoroquinolones (FQ) have been reported to be associated with the acute neuropsychiatric events in numerous case reports. However, few population‐based studies have investigated this association.

Objectives: To estimate the incidence rate ratio (IRR) of acute neuropsychiatric events among patients prescribed oral FQ in Hong Kong.

Methods: We used the self‐controlled case series method to conduct the analysis using data collected from the Clinical Data Analysis and Report System in Hong Kong. Patients with at least one oral FQ prescription and a neuropsychiatric event between 2001‐2013 were identified. Those with a history of neuropsychiatric events were excluded. The rates of event occurrence during risk periods were compared to the non‐risk periods to estimate the IRR. The risk periods were predefined as before, during and after FQ exposure. Poisson regression adjusted for age was used. The crude absolute risk of having a neuropsychiatric event during current FQ use was also estimated.

Results: There were 291,751 oral FQ prescribed to 166,325 patients between 2001‐2013. A total of 4,287 patients were included in the analysis. An increased risk was observed in current FQ use [IRR: 2.12 (95% Confidence Interval 1.58‐2.83)] and 1‐7 days immediately after FQ completion [1.90 (1.30‐2.75)]. There was no increased risk observed in other risk periods. A total of 50 neuropsychiatric events occurred during current FQ use. The estimated crude absolute risk of having a neuropsychiatric event during current FQ use was 1.70 (1.30‐2.26) case per 10,000 oral FQ prescriptions.

Conclusions: The findings of this study supports an association between the use of oral FQ and neuropsychiatric events. The association is acute and appeared to be short‐term. However, based on the estimated crude absolute risk, the occurrence of such event is rare.