Cohort studyindependent cross-checkabstract checked★ key study I-ABX-124 standard review

International study: no aortic risk from fluoroquinolones for urinary infections

Risk of aortic aneurysm or dissection following use of fluoroquinolones: a retrospective multinational network cohort study.

Overview

Janetzki JL et al.. EClinicalMedicine 2025 · PMID 39975698 · DOI 10.1016/j.eclinm.2025.103096

In 13.6 million patients, fluoroquinolones did not raise aortic aneurysm/dissection risk versus other antibiotics.

Does the study support the specific claim? No · Methodological quality: high

Study explained simply

What did the researchers want to find out?: Test aortic risk in UTI treatment
How was the study done?: Network cohort
How many people, animals or samples were studied?: 13.6 million patients
What was actually found?: No extra risk
How large was the observed effect?: HR 0.91-1.01
What do the results mean in everyday life?: The aortic warning may be overstated
What are the study's limitations?: UTI only
What does it say about Elawady's specific claim?: Contradicts the aortic part
Do the results apply to Germany and Europe?: Moderate
What can explicitly not be concluded from this study?: Risk for other uses

Authors: Janetzki JL et al.
Journal: EClinicalMedicine
Year: 2025
Identifier: PMID 39975698 DOI 10.1016/j.eclinm.2025.103096
Verification: verified – PubMed efetch 2026-10-26 + Crossref
Retracted: no
Corrections: none
Extent checked: abstract only
Conflicts of interest and funding: Korean, Australian NHMRC and US VA funding; some authors with consulting relationships (record).

Do fluoroquinolones increase AA/AD risk compared with other UTI antibiotics?

Study design: Cohort study – Multinational network cohort (14 databases, 5 countries), propensity matching, empirical calibration
Population: Patients >=35 years starting outpatient antibiotics for UTI
Country: USA, South Korea, Japan, Taiwan, Australia
Period: 2010-2019
Sample size: 13,588,837 patients; 1,954,798 and 1,195,962 matched pairs
Inclusion and exclusion criteria: No hospitalisation within 7 days; >=365 days observation

Exposure / intervention: Fluoroquinolones
Comparator: Trimethoprim(-sulfamethoxazole); cephalosporins
Endpoints: AA/AD within 60 days
Statistical methods: PS-matched Cox; negative-control calibration; Bayesian random-effects

Results: No difference vs trimethoprim (ARD 0.21 per 1000 person-years; calibrated HR 0.91, 95% CI 0.73-1.10) or vs cephalosporins (ARD 0.11 per 1000 person-years; HR 1.01, 0.82-1.25).
Absolute risks: ARD 0.21 and 0.11 per 1000 person-years
Authors' conclusion: No increased risk of AA/AD associated with fluoroquinolones compared with trimethoprim or cephalosporins in outpatient UTI.

Narrow null estimates.

Second rigorous null study for the aortic element.

Restricted to UTI.

Moderate.

Together with Brown 2023, makes the aortic risk uncertain.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	high
Risk of bias	low
Precision of results	high
Directness	direct
Reproducibility	replicated
Consistency with the overall evidence	mixed
Regional transferability	moderate
Adequacy of the interpretation (by the archive)	not applicable

Other indications.