Fluoroquinolone antibiotics have been found to increase the risk of aortic aneurysm or dissection, according to the Food and Drug Administration (FDA).
This association was identified after a review of cases reported to the FDA Adverse Event Reporting System (FAERS) and 4 observational studies (between 2015 and 2018) showed an increased risk of aortic aneurysm or dissection with fluoroquinolone use. Pooled study data demonstrated consistent evidence of this association although the varied study designs and methods could have affected the data.
“Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert healthcare professionals and patients,” the Agency’s safety communication stated. However, due to study limitations, the FDA has not determined a definite causal association.
As a result of the findings, the FDA is requiring a new warning be added to the prescribing information and Medication Guide for all fluoroquinolones describing this risk. For patients at increased risk for aortic aneurysms (ie, history of peripheral atherosclerotic vascular diseases, hypertension, Marfan syndrome, Ehlers-Danlos syndrome, elderly) treatment with fluoroquinolones should be reserved for when no other options are available.
Currently available systemic fluoroquinolones include: ciprofloxacin, ciprofloxacin extended-release, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin. Since 2008, several alerts have been issued regarding safety issues surrounding fluoroquinolones, including tendon rupture, peripheral neuropathy, and mental health side effects. In 2016, the FDA restricted the use of fluoroquinolones for certain uncomplicated infections.
For more information visit FDA.gov.