(Reaffirmed October 2020)
(Replaces July 20, 2018, ACOG Practice Advisory, “New FDA Safety Warning for Fluoroquinolone Antibiotics”)
The U.S. Food and Drug Administration (FDA) has updated its drug safety information for oral and injectable fluoroquinolone antibiotics to include the rare but serious risk of aortic ruptures or tears in certain patients 1. The FDA advises that health care providers should not prescribe systemic fluoroquinolones for patients who have an aortic aneurysm or are at risk of 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) unless no other treatments are available 1. This updated warning will be added to the prescribing information and patient medication guide for all fluoroquinolones for systemic use.
This latest safety communication reinforces existing guidance from the FDA, which advises against prescribing systemic fluoroquinolones to patients who have other treatment options for bacterial infections, including uncomplicated urinary tract infections, because the risks outweigh the benefits in these patients 2. Potential risks associated with fluoroquinolone use include hypoglycemic coma and certain adverse mental health effects 3; disabling and potentially permanent adverse effects to the tendons, muscles, joints, nerves, and central nervous system 4; peripheral neuropathy 4; and tendinitis and tendon rupture 4.
The FDA is continuing to assess safety issues with fluoroquinolones as part of its ongoing review of drugs and will provide updates if additional actions are needed. See the FDA’s Fluoroquinolone Antimicrobial Drugs Information page for more information 5.