{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T18:45:59Z","timestamp":1791398759346,"version":"4.3.3"},"reference-count":50,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T00:00:00Z","timestamp":1776124800000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Fluoroquinolones (FQs) are among the most frequently prescribed antibiotic classes worldwide. Despite their therapeutic versatility in treating bacterial infections, regulatory authorities recognized risks of persistent and potentially irreversible adverse effects, particularly peripheral neuropathy (PN). However, a comprehensive pharmacovigilance assessment of PN\u2010related adverse events (AEs) across all six FDA\u2010approved FQs remains limited. We therefore analyzed adverse event reports (AERs) associated with these six agents from the FDA Adverse Event Reporting System (FAERS) Public Dashboard spanning 2007\u20132024 Q3, following READUS\u2010PV guidelines. Disproportionality analysis was conducted to identify potential safety signals for PN\u2010related AEs reported with FQ use following deduplication and exclusion of cases involving non\u2010FQ concomitant medications. Positive disproportionality signals were observed for the commonly prescribed FQs (ciprofloxacin, levofloxacin, moxifloxacin, and ofloxacin), with seven distinct PN manifestations generating signals. Notably, we detected PN\u2010related signals for gemifloxacin, a relatively new FQ with limited prior evaluation of neurotoxicity. Univariate logistic regression revealed that women and adults aged 18\u201364\u2009years were more frequently represented in FQ\u2010associated PN\u2010related AERs, whereas men and patients aged \u2265\u200965\u2009years were disproportionately represented among cases with fatal outcomes. Combination therapy with multiple FQs generated disproportionality signals exceeding those with FQ monotherapy. These findings underscore the need for increased vigilance when prescribing FQs, particularly for mild infections where risks may outweigh benefits. Strengthened clinical monitoring for early signs of PN is advisable when FQ treatment becomes unavoidable. Further controlled epidemiological studies are needed to validate these signals and define at\u2010risk groups, alongside mechanistic research aimed at supporting the development of neuroprotective strategies.<\/jats:p>","DOI":"10.1111\/cts.70541","type":"journal-article","created":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T03:29:23Z","timestamp":1776223763000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Disproportionality Analysis of Fluoroquinolone\u2010Associated Peripheral Neuropathy in the\n                    <scp>FAERS<\/scp>\n                    Database (2007\u20132024)"],"prefix":"10.1111","volume":"19","author":[{"given":"Nimra","family":"Shamim","sequence":"first","affiliation":[{"name":"School of Medicine, Pharmacy and Biomedical Sciences, Faculty of Science and Health University of Portsmouth  Portsmouth UK"},{"name":"Institute of Life Sciences and Healthcare University of Portsmouth  Portsmouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Doughty","sequence":"additional","affiliation":[{"name":"School of Medicine, Pharmacy and Biomedical Sciences, Faculty of Science and Health University of Portsmouth  Portsmouth UK"},{"name":"Institute of Life Sciences and Healthcare University of Portsmouth  Portsmouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hau\u2010Tak","family":"Chau","sequence":"additional","affiliation":[{"name":"Department of Medicine, School of Clinical Medicine The University of Hong Kong  Hong Kong SAR Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Brown","sequence":"additional","affiliation":[{"name":"School of Medicine, Pharmacy and Biomedical Sciences, Faculty of Science and Health University of Portsmouth  Portsmouth UK"},{"name":"Institute of Life Sciences and Healthcare University of Portsmouth  Portsmouth 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