(SLA-058) Exploring the Association between Fluoroquinolones and Neuropsychiatric Adverse Events: A Scoping Review

Background: Drug regulatory authorities continue to be concerned about neuropsychiatric adverse events associated with fluoroquinolone use. However, real-world studies investigating this safety issue remain limited.

Objectives: We aimed to conduct a scoping review to assess real-world studies which examined the association between fluoroquinolones and neuropsychiatric adverse events, with a particular focus on suicide, depression, and anxiety, and to identify potential gaps of knowledge on this topic.

Methods: We conducted a systematic search of literature published in PubMed from inception to January 15, 2025, using full-text and Medical Subject Headings terms including fluoroquinolones, neuropsychiatric disorders, suicide, depression, and anxiety. We also summarized the study types, data source, and main findings of the available studies.

Results: A total of 26 studies were identified, including one systematic review of case reports, 15 case reports or case series, five pharmacovigilance studies, and five population-based studies (two cohort studies, two nested case-control studies, and one self-controlled case series study). The five population-based studies were mainly conducted in the Western countries (n=4); three adopted a non-user comparison design and two adopted an active comparison approach. There was an up to 2-fold increased risk of suicide, depression, or anxiety associated with fluoroquinolones compared to non-use of fluoroquinolones. However, the risk was toward the null when compared to other antibiotics. Of note, only one cohort study reported an absolute risk estimate of suicide and no studies examined potential intra-class differences between fluoroquinolones.

Conclusions: Whether there is an increased risk of neuropsychiatric adverse events associated with fluoroquinolones seems to depend on the choice of comparison groups. There is also a paucity of information on absolute risk estimates and risk for individual fluoroquinolones. Further well-designed observational studies are needed to address these gaps of knowledge.