Time to Broaden Warning on Fluoroquinolones to All Adults?

By Reuters Staff

January 19, 2021

NEW YORK (Reuters Health) - A new study confirms and strengthens the association between fluoroquinolone antibiotics and increased risk of aortic aneurysm, prompting calls to broaden warnings to include all adults, not just high-risk adults.

In December 2018, the U.S. Food and Drug Administration (FDA) updated its May 2017 safety alert stating that fluoroquinolone antibiotics should not be used in patients at increased risk of aortic disease.

The new study, published in JAMA Surgery, suggests that fluoroquinolones "should be used with caution among individuals aged 35 years or older, regardless of sex or comorbidities," say Dr. Melina Kibbe and colleagues with the University of North Carolina at Chapel Hill.

Theirs was a retrospective analysis of insurance claims from 2005 to 2017 for adults aged 18 to 64 years. Among the more than 47 million antibiotic prescriptions filled, about 9 million (19%) were for fluoroquinolones and 38.5 million (81%) for comparator antibiotics.

Before weighting, the 90-day incidence of newly diagnosed AA formation or dissection was higher with fluoroquinolones than other antibiotics (7.5 vs. 4.6 per 10,000 fills), report Dr. Melina Kibbe and colleagues with the University of North Carolina at Chapel Hill.

After weighting for demographic factors and comorbid conditions, fluoroquinolone use was associated with a 20% increased incidence of aneurysm formation (hazard ratio, 1.20; 95% confidence interval, 1.17 to 1.24).

The association was primarily for 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). These individuals were more likely to undergo aneurysm repair (HR, 1.88; 95% CI, 1.44 to 2.46).

This association was consistent across adults aged 35 years or older, sex and comorbidities.

"Contextualizing these data, we believe that the current U.S. FDA black box warnings are warranted but may need to be expanded to include younger adults with other risk factors," they advise.

The authors of a commentary in JAMA Surgery agree.

"This large cohort study of a U.S. population suggests it is time once again to rethink the use of this class of antibiotics for patients with or without aortic disease (and) we encourage FDA to broaden their warning recommendations," write Dr. Amanda Filiberto and Dr. Gilbert Upchurch Jr. of the University of Florida College of Medicine, in Gainesville.

The study had no commercial funding and the authors have declared no conflicts of interest.

SOURCE: http://bit.ly/3q1P9pw https://bit.ly/3oBnhbT JAMA Surgery, online January 6, 2021.