Etminan M, Sodhi M, Ganjizadeh-Zavareh S, et al. Oral Fluoroquinolones and Risk of Mitral and Aortic Regurgitation. J Am Coll Cardiol. 2019 Sep 17;74(11):1444-1450. doi: 10.1016/j.jacc.2019.07.035. (Original study)

BACKGROUND: Recent studies have linked fluoroquinolones (FQs) to cardiac adverse events, including aortic dissection and aneurysm. To date, whether FQs can increase the risk of aortic or mitral regurgitation has not been studied.

OBJECTIVES: This disproportionality analysis and case-control study examined whether FQs increase the risk of aortic and mitral regurgitation.

METHODS: Data from the U.S. Food and Drug Administration's adverse reporting system database was used to undertake a disproportionality analysis, and a random sample of 9,053,240 patients from the U.S. PharMetrics Plus database (IQVIA) was used for the matched nested case-control study. Current FQ exposure implied an active prescription at the index date or 30 days prior to the event date. Recent FQ exposure was defined as FQ use within days 31 to 60 and past within days 61 to 365 prior to the event date. Rate ratios (RRs) were compared to users of amoxicillin and azithromycin. Conditional logistic regression was used to compute RRs adjusting for confounders.

RESULTS: The reported odds ratio for the disproportionality analysis was 1.45 (95% confidence interval [CI]: 1.20 to 1.77). A total of 12,505 cases and 125,020 control subjects were identified in the case-control study. The adjusted RRs for current users of FQ compared with amoxicillin and azithromycin users were 2.40 (95% CI: 1.82 to 3.16) and 1.75 (95% CI: 1.34 to 2.29), respectively. The adjusted RRs for recent and past FQ users when compared with amoxicillin were 1.47 (95% CI: 1.03 to 2.09) and 1.06 (95% CI: 0.91 to 1.21), respectively.

CONCLUSIONS: These results show that the risk of aortic and mitral regurgitation is highest with current use followed by recent use. No risk was observed with past use of FQs. Future studies are necessary to confirm or refute these associations.

Discipline Area Score
Infectious Disease 6 / 7
Internal Medicine 6 / 7
Cardiology 6 / 7
Family Medicine (FM)/General Practice (GP) 5 / 7
General Internal Medicine-Primary Care(US) 5 / 7
Comments from MORE raters

Cardiology rater

Very interesting premise that administration of antibiotic class of drugs can cause tissue injury and thereby cause cardiac injury. Clinicians should consider reading the full article.

General Internal Medicine-Primary Care(US) rater

This is novel information and quite relevant to primary care. I would like to see data from additional sources before making changes in clinical practice or sharing this information with patients.

Infectious Disease rater

This large study shows that in 2 databases, fluoroquinolones were associated with an increased relative risk of valvular problems. Unfortunately, this study design does not allow calculation of absolute risk.

Infectious Disease rater

This is an important adverse event that is often underappreciated. The study has some obvious issues, but more attention should be given to this AE.

Infectious Disease rater

There is an increasing number of reasons to avoid fluoroquinolone (FQ) use, valvular regurgitation being the most recent, as described here. FQs are commonly used go-to drugs for a variety of community- and hospital-acquired infections, so clinicians should be familiar with all their adverse effects including the serious one described here.
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