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FDA Warning: Fluoroquinolones Increases Risk for Aortic Dissection and Aneurysm

Thursday, January 3, 2019

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Source Name: FDA Safety Alerts for Human Medical Products


US Food and Drug Administration

On December 20, 2018, the US Food and Drug Administration (FDA) issued a new warning against the use of fluoroquinolones in patients with connective tissue disorders and those predisposed to aortic disease.

The FDA indicates that fluoroquinolones, a commonly prescribed class of antibiotics (including Avelox, Cipro, Factive, Levaquin, and Ofloxacin), should not be used in certain patients with aortic aneurysm/dissection and those who are at higher risks for developing aortic aneurysms and dissections, such as patients with connective tissue disorders, hypertension, peripheral atherosclerotic vascular diseases, and the elderly. A review of several recent studies shows that people who have taken a fluoroquinolone are twice as likely to develop an aortic aneurysm or dissection than those who have not taken one of these drugs. FDA has also required a new warning about this risk to be added to the labeling of these medications.

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