Fluoroquinolones and Aortic Disease—Is It Time to Broaden the Warning?

Abstract

In this issue of JAMA Surgery, Newton et al 1 present findings from a retrospective analysis of MarketScan Commercial Database health insurance claims data that documents that fluoroquinolone use vs comparator antibiotics is associated with an increased incidence of aortic aneurysm (AA) formation within 90 days in a large cohort of US adults. Mechanistically, this association is primarily for abdominal aortic and iliac artery aneurysms, not aortic dissections (ADs) or thoracic aortic aneurysms. The association was present across all age groups (≥35 to <65 years) and was consistent across sex and comorbidities. The study also documents that adult patients were more likely to undergo aneurysm repair (hazard ratio, 1.88; 95% CI, 1.44-2.46).The authors point out that, in December 2018, the US Food and Drug Administration (FDA) issued an update to the May 2017 FDA safety announcement stating that fluoroquinolones should not be used for patients at "increased risk" of aortic disease. This recommendation was based on 4 international epidemiological studies, which all showed that use of fluoroquinolones was associated with an increased risk of AA or AD. 2 One additional study published in 2019, since the FDA update, used the World Health Organization's Vigibase database of individual case safety reports and again found that fluoroquinolone use was associated with a higher risk of AA or AD (reporting odds ratio, 2.13; 95% CI, 1.03-4.37). 3 A metaanalysis of all 5 of these studies concluded that, compared with nonusers or with users of comparator antibiotics, fluoroquinolone users had a significantly increased risk of aortic disease (adjusted odds ratio, 2.23; 95% CI, 1.80-2.77). 4 The authors succinctly summarize the available literature among human and animal studies consistent with their findings, sug-

Fluoroquinolone-Induced Aortic Injury

“…Риск поражения аорты возрастает с увеличением дозы и длительности применения ФХ [18]. Как правило, поражение аорты на фоне приема ФХ развивалось в течение 60-90 сут с начала терапии [2,8,9,19]. Согласно данным C. C. Lee и соавт., терапия ФХ в течение 3-14 сут приводила к возрастанию риска развития аневризмы и диссекции аорты в 2,41 раза, а дольше 14 сут -в 2,83 раза [15].…”