Fluoroquinolone Antibiotic Risks Outweigh the Benefits in Certain Patients: FDA Safety Warning


The FDA has issued label updates for a handful of fluoroquinolone antibiotics to note the risk of aortic dissections and aortic aneurysms in certain patients.

Update May 7, 2019:

The US Food and Drug Administration (FDA) has released label updates for the following products to incorporate the warnings about aortic dissections or aortic aneurysm ruptures.

Cipro NDA #019537

Cipro In Dextrose 5% In Plastic Container NDA #019857

Levaquin NDA #020634

Cipro NDA #020780

Avelox NDA #021085

Factive NDA #021158

Avelox In Sodium Chloride 0.8% In Plastic Container NDA #021277

Cipro Xr NDA #021473

Kadcyla BLA #125427

Moxifloxacin Hydrochloride NDA #205572

Baxdela NDA #208610

Baxdela NDA #208611

December 21, 2018:

Fluoroquinolone antibiotics can contribute to the occurrence of rare but serious events in certain patients, such as aortic dissections or aortic aneurysm ruptures, which can be deadly, the US Food and Drug Administration warned Thursday, December 20, 2018, in a safety alert.

The risks of taking fluoroquinolone antibiotics may outweigh the benefits, according to the FDA, and health care professionals should avoid prescribing these medications “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.”

Scott Gottlieb, MD, FDA Commissioner, tweeted the safety alert, noting that alternative treatments should be considered.

For patients with, or at risk of aortic aneurysm (elderly, aortic blockage history, high blood pressure, certain genetic conditions) we do not believe the benefits of taking fluoroquinolones outweigh this risk. Alternative treatment should be considered. https://t.co/jGwmy9SrOc?rel=0" ?rel=0"

— Scott Gottlieb, M.D. (@SGottliebFDA) December 20, 2018

“For patients with, or at risk of aortic aneurysm (elderly, aortic blockage history, high blood pressure, certain genetic conditions) we do not believe the benefits of taking fluoroquinolones outweigh this risk,” he tweeted. “Alternative treatment should be considered.”

There has been a lot of chatter over the last few years regarding the risks of fluoroquinolones to many patient groups.

In July, the FDA mandated safety label changes to further highlight the risks of mental health side effects and serious blood sugar disturbances.

In October, Contagion® reported that the Pharmacovigilance Risk Assessment Committee—the safety committee of the European Medicines Agency—recommended restricting fluoroquinolone use for certain conditions, including self-resolving infections, lower urinary tract infections, traveler’s diarrhea, because of persistent and serious adverse reactions.

Numerous studies have also raised safety concerns about the association between fluoroquinolone treatment and rare but serious and debilitating adverse events in muscles, joints, and the central nervous system. Moreover, the use of fluoroquinolones has been associated with increased rates of Clostridium difficile infection and resistance among Staphylococcus aureus and gram-negative organisms.

In a June video interview with Contagion®, Barbara Wells Trautner, MD, PhD, associate professor, director of clinical research, Baylor College of Medicine, addressed the risk aortic dissection and aneurysm in patients taking oral fluoroquinolone.

“There were actually 2 studies that came out in 2015,” she said. “One, in JAMA Internal Medicine was performed in Korea, and the other was a study in Canada. Both are very large data studies, and both show there is an increased risk of aneurysm and dissection during the time patients are taking fluoroquinolones.”

Moving forward, the FDA will continue to monitor and communicate any updates on safety concerns regarding fluoroquinolone, Dr. Gottlieb tweeted.

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