New FDA Warning – Quinolone Antibiotics Increase Risk of Aortic Dissection

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On December 20, 2018, the US Food and Drug Administration issued a new warning regarding the risk aortic dissection in patients being treated with fluoroquinolone antibiotics.  While this adverse effect is rare, aortic dissection (rupture or tear in the aorta) can be fatal.

This new warning comes after the FDA completed a review of several published observational studies that showed consistent evidence of an association between risk of aortic dissection and fluoroquinolone use, and reverses a statement made by the FDA in 2017 when they were unable to verify an association.   While the underlying cause of this adverse effect is unclear, these studies showed the risk of aortic dissection to be twice as high as the background risk for patients who are taking fluoroquinolone antibiotics.

The FDA recommends that fluoroquinolones not be used in patients at increased risk of aortic dissection unless all other treatment options have been exhausted.  Patients at increased risk of aortic dissection include those with a history of aortic blockages or aneurysms (abnormal bulges of the aorta) or other blood vessels, high blood pressure, genetic disorders that involve blood vessel changes (such as Marfan syndrome and Ehlers-Danlos syndrome), and the elderly.  This warning is now required in the prescribing information of these agents.

References

To access the FDA announcement, click here.


Additional information about fluoroquinolones, including ciprofloxacin, gatifloxacin, levofloxacin and moxifloxacin can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Flash Card section.  If your institution does not provide access, ask your medical librarian about subscribing.

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Go to the profile of Jill Kolesar & Lee Vermeulen

Jill Kolesar & Lee Vermeulen

Professors, University of Kentucky

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