Takeaway
- Use of oral fluoroquinolones is linked to an increased risk for mitral and aortic regurgitation.
- Risk appears to be highest with current use; no associations observed among past users (>60 days postexposure).
- Additional research is needed. See related editorial.
Why this matters
- Consider non-fluoroquinolone antibiotics for patients with prior valvular regurgitation.
Key results
- Cohort study of 8,272,981 patients including 12,502 valvulopathy cases and 125,020 controls (mean age, 58.1+12.7 years).
- Disproportionality study: 102 reports of valvular regurgitation with fluoroquinolones, 6099 reports with other drugs (reporting OR, 1.45; 95% CI, 1.20-1.77).
- Case control: adjusted rate ratio (aRR) for combined mitral/aortic regurgitation with current fluoroquinolone use:
- 2.40 vs amoxicillin (95% CI, 1.82-3.16).
- 1.75 vs azithromycin (95% CI, 1.34-2.29).
- aRR for recent use (31-60 days) was significant vs amoxicillin (1.47; 95% CI, 1.03-2.09) but not azithromycin (1.37; 95% CI, 0.95-1.98).
- The risk for past use (>60 days) of fluoroquinolones vs amoxicillin and
azithromycin was very close to 1.00.
Study design
- Drug adverse event disproportionality analysis comparing valvular regurgitation cases with fluoroquinolones vs other antibiotics during 2004-2018.
- Case-control analysis to determine if fluoroquinolones increase aortic/mitral regurgitation risk.
- Database: US FDA Adverse Event Reporting System (FAERS).
- Funding: British Columbia Provincial Health Services Authority.
Limitations
- Reporting bias.
- No data on unmeasured confounders.
- Bias toward the null.
- Limited generalizability.
References
References