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Fluoroquinolone-Associated Peripheral and Central Nervous System-Related Disorders: A Large German Claims-Based
Julia Wicherski1, Jonas Peltner2, Cornelia Becker1
1Federal Institute for Drugs and Medical Devices (BfArM), Research Division, Pharmacoepidemiology, Bonn, Germany.
European Journal of Neurology
|March 26, 2026
Summary
Newly prescribed fluoroquinolones (FQ) are linked to a higher risk of neurological and neuropsychiatric events, particularly within 92 days of use. These risks differ across age and gender demographics.
Area of Science:
- Pharmacovigilance
- Neurology
- Psychiatry
Background:
- Fluoroquinolones (FQ) are broad-spectrum antibiotics with known potential adverse effects.
- Neurological and neuropsychiatric events are serious concerns associated with antibiotic use.
Purpose of the Study:
- To investigate the association between new fluoroquinolone prescriptions and the incidence of polyneuropathy and specific neuropsychiatric events.
- To quantify the risk of these events in patients prescribed FQ compared to other antibiotics.
Main Methods:
- A German statutory health insurance-based cohort study (2013-2019) comparing FQ to reference antibiotics.
- Follow-up of patients for 365 days post-prescription for outcomes including peripheral nervous system (PNS) diseases, depression (DEP), mood (MOOD), somnolence/coma (SSC), and consciousness (CONSCIOUS) symptoms.
- Statistical analysis using piece-wise exponential additive mixed models adjusted for covariates.
Main Results:
- Relative risks for FQ versus reference antibiotics ranged from 1.04 to 1.10 for the studied outcomes.
- Elevated risks were observed in specific subgroups: PNS in young males, MOOD and CONSCIOUS in middle-aged females, DEP in older males, and SSC in young females.
- FQ-associated PNS was largely drug-induced polyneuropathy (aHR = 1.68).
Conclusions:
- Fluoroquinolone use is associated with an increased risk of neurological and neuropsychiatric events.
- The heightened risk is most pronounced within the first 92 days following initial FQ dispensing.
- Risk stratification by age and gender is crucial for understanding FQ-associated adverse events.
Keywords:
active comparator new user designadministrative cohortadverse drug reactionsfluoroquinolonesreal‐world dataMore Related Videos
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