GenTAC Alliance Statement on FDA and PRAC Warning Concerning Fluoroquinolones

Statement Concerning Fluoroquinolones and the Risk of Aortic Complications

In late 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency and the US Food and Drug Administration (FDA) issued warnings against the use of fluoroquinolones in people with genetic thoracic aortic diseases, specifically including Marfan syndrome and vascular Ehlers-Danlos syndrome. Fluoroquinolones are a commonly prescribed class of antibiotics that includes Cipro, Levaquin, Ofloxacin, Avelox, and Factive. The warnings were based on several recent observational clinical studies that demonstrated that fluoroquinolone use is associated with an increased risk of aortic aneurysm, dissection, and rupture. Laboratory experiments have confirmed a plausible biological explanation for how Cipro—the most commonly prescribed fluoroquinolone in the US—can promote aortic wall degeneration, dissection, and rupture.

Physicians should not prescribe fluoroquinolones to people with genetic thoracic aortic diseases—including those with Marfan, vascular Ehlers-Danlos, and Loeys-Dietz syndromes—unless no other treatment options are available. Before a patient starts an antibiotic prescription, they should inform their healthcare professional about their genetic condition and any history of aortic aneurysm or dissection. If a patient has been prescribed a fluoroquinolone to treat an infection, they should not stop the antibiotic without first talking to their healthcare provider. As always, if a patient experiences sudden, severe pain in the chest, back, or abdomen, they should go to an emergency room immediately.

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Disclaimer: The opinions expressed in the above statement are those of the GenTAC Alliance Clinical Science Working Group.