Methods:

In recent years, adverse events such as retinal detachment, tendon rupture, and aortic aneurysms and dissection have been attributed to FQ use, with more recent case reports of valvular prolapse. The in vitro ability of FQ to damage connective tissue and collagen has been proposed as the causative mechanism. This study sought to assess the association between FQ use and increased risk of mitral and aortic regurgitation.

First, a disproportionality analysis was performed using the Food and Drug Administration (FDA)’s Adverse Events Reporting System (FAERS) database, which includes all reported prescription drug-related adverse events from 2004-2018. Authors compared valvular regurgitation reports linked to FQs versus those linked to all other drugs to generate reporting odds ratios (RORs) and corresponding confidence intervals (CIs).

Next, a nested case-control study was performed using the US PharMetrics Plus health claims database, applying International Classification of Diseases (ICD)-9 and -10 codes related to mitral and aortic valve regurgitation. Conditions that independently increased the risk of valvular regurgitation (e.g., endocarditis, rheumatic fever, strep throat) and several other disorders (e.g., tricuspid valve disease, myocarditis, and mitral stenosis) were excluded prior to identification of cases. Each case was matched to 10 control subjects based on age, follow-up time, and index date. The authors calculated risk ratios (RRs) for FQ use relative to two other antibiotics, amoxicillin and azithromycin. Cases were divided into current (within 30 days), recent (31-60 days) or past use (61-365 days). Finally, a conditional logistic regression model was used to adjust crude RRs for age, gender, atrial fibrillation, coronary artery disease, stroke, and exposure to certain drugs (e.g., phentermine).