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ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Neuropharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1556159
Suicidal Thoughts and Behaviors Associated with Fluoroquinolone Antibiotics: A Real-World Pharmacovigilance Analysis
Provisionally accepted- Xiamen University Affiliated Cardiovascular Hospital, Xiamen, China
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Objective: This study aimed to systematically and scientifically investigate the potential associations between the use of fluoroquinolone antibiotics (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, norfloxacin, and delafloxacin) and suicidal thoughts and behaviors using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database.The FAERS database was queried from the first quarter of 2004 to the fourth quarter of 2023. Disproportionality analysis was conducted using the reporting odds ratio (ROR) and empiricalResults: A total of 737 cases of suicidal thoughts and behaviors associated with fluoroquinolones (FQs) were reported in the FAERS database during the study period. Overall, FQs did not demonstrate a disproportionate increase in overall cases of suicidal thoughts and behaviors (ROR: 0.74, 95% CI: 0.69-0.79, P < 0.001; EBGM05: 0.69). Stratified analyses revealed no safety signals for suicidal thoughts and behaviors associated with FQs in either females or males. However, subgroup analyses by age groups demonstrated slightly elevated RORs for suicidal thoughts and behaviors in the <18 years age group (ROR: 1.51, 95% CI: 1.05-2.19, P = 0.03) and the 18-24 years age group (ROR: 2.31, 95% CI: 1.75-3.06, P < 0.001), although the EBGM05s values remained below 2 in both populations. No significant safety signals were observed in the other age groups.The analysis of reported cases of suicidal thoughts and behaviors in the FAERS database does not indicate an overall safety signal associated with fluoroquinolones (FQs) at present. Subgroup analysis revealed a slight increase in the RORs for suicidal thoughts and behaviors in the <18 years and the 18-24 years age group; however, no significant safety signal was detected based on the EBGM05s in these populations. Further comprehensive and prospective studies are necessary to confirm and validate these findings.
Keywords: FAERS, Fluoroquinolones, Pharmacovigilance, Suicidal thoughts, Suicidal behaviors
Received: 06 Jan 2025; Accepted: 08 Apr 2025.
Copyright: © 2025 Yang, Chen, Ding, Lu, Li and Xiao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Lijuang Yang, Xiamen University Affiliated Cardiovascular Hospital, Xiamen, China
Jie Xiao, Xiamen University Affiliated Cardiovascular Hospital, Xiamen, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.