Fluoroquinolone use was associated with an increased incidence of aortic aneurysm formation within 90 days in a large cohort of U.S. adults when compared with other antibiotics, according to a recent cohort study.
Researchers examined prescription fills for fluoroquinolones or a comparator antibiotic (amoxicillin-clavulanate, azithromycin, cephalexin, clindamycin, or sulfamethoxazole-trimethoprim) from 2005 to 2017 among commercially insured patients. The cohort included more than 27.8 million U.S. adults who had no known previous aortic aneurysm or dissection, recent antibiotic exposure, or recent hospitalization. The main outcome measure was 90-day incidence of aortic aneurysm and dissection. Study results were published Jan. 6 by JAMA Surgery.
Among a total of 47,596,545 prescription fills, 9,053,961 (19%) were fluoroquinolones and 38,542,584 (81%) were comparator antibiotics. The 90-day incidence of newly diagnosed aneurysm was 7.5 cases per 10,000 fills (6,752 of 9,053,961) after fluoroquinolones compared with 4.6 cases per 10,000 fills (17,627 of 38,542,584) after comparator antibiotics in unweighted data. When demographic characteristics and comorbid conditions were considered, fluoroquinolones were associated with increased incidence of aneurysm formation (hazard ratio [HR], 1.20; 95% CI, 1.17 to 1.24). Fluoroquinolones were associated with increased 90-day incidence of abdominal aortic aneurysm (HR, 1.31; 95% CI, 1.25 to 1.37), iliac artery aneurysm (HR, 1.60; 95% CI, 1.33 to 1.91), and other abdominal aneurysm (HR, 1.58; 95% CI, 1.39 to 1.79) versus comparator antibiotics.
When stratified by age, all adults age 35 years or older appeared to be at increased risk (HR, 0.99 [95% CI, 0.83 to 1.18] for those ages 18 to 24 years, 1.18 [95% CI, 1.09 to 1.28] for those 35 to 49 years, and 1.24 [95% CI, 1.19 to 1.28] for those 50 to 64 years; P=0.04). No differences were seen when data were stratified by sex and common comorbid conditions, such as hypertension and hyperlipidemia. The researchers wrote that the association of fluoroquinolone use with the aneurysm rate was consistent, suggesting a drug class risk among both healthy and unhealthy individuals and indicating that fluoroquinolones should be used with caution among those ages 35 years or older, regardless of sex or comorbidities.
An accompanying invited commentary said the study results suggest that “it is time once again to rethink the use of this class of antibiotics for patients with or without aortic disease. We wholeheartedly agree with the authors that fluoroquinolone use ‘should be pursued with caution in all adults, not just in high-risk individuals,’ and we encourage the FDA to broaden their warning recommendations.”