GenTAC Alliance Statement on Recent FDA Warning Concerning Fluoroquinolones

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On December 20, 2018, the FDA warned that fluoroquinolone antibiotics should not be prescribed to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients. Drugs in this category include: Avelox (moxifloxacin), Baxdela (delafloxacin), Cipro (ciprofloxacin), Factive (gemifloxacin), Levaquin (levofloxacin), and generic ofloxacin.

The GenTAC Alliance suggests that, for patients with known thoracic aortic aneurysms or who have the noted risk factors:

  • The use of fluoroquinolones should be limited to situations where other antibiotics would not be an effective option.
  • Patients should seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.  Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.  If you have been prescribed a fluoroquinolone to treat an infection, do not stop the antibiotic without first talking to your health care professional.