FDA Warns of Aortic Aneurysm Risk with Levaquin, Other Fluoroquinolone Antibiotics

Published on December 27, 2018 by Sandy Liebhard

Federal drug regulators have once again issued a new side effect warning for fluoroquinolones, a class of antibiotics that includes Levaquin, Cipro, and Avelox, among others.

This time, the U.S. Food & Drug Administration (FDA) cautioned that Levaquin and similar antibiotics may increase a patients’ risks for aortic aneurysm and aortic dissection.

Aortic dissections are tears that occur in the aorta, the body’s main blood vessel. Aortic aneurysms are bulges that can cause the aorta to rupture. Both may result in dangerous bleeding or even death.

What Patients Should Know About Levaquin Aortic Injuries

According to an FDA Drug Safety Communication published on December 20th,  these life-threatening aortic side effects are associated with the use of systemic fluoroquinolone (those administered orally or via injection). The agency’s conclusions were based on a review of adverse event reports and several published studies.

“Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert health care professionals and patients,” the agency said.

When other options are available, doctors should avoid prescribing these drugs to patients at risk for aortic injuries, including:

  • Individuals with a history of blockages or aneurysms of the aorta or other blood vessels
  • Those with peripheral atherosclerotic vascular disease
  • Patients with high blood pressure
  • Those with certain genetic disorders that involve blood vessel changes (such as syndrome and Ehlers-Danlos syndrome)
  • The elderly

Fluoroquinolone patients should go to the nearest emergency room or call 911 if they experience sudden, severe, and constant pain in the stomach, chest or back.

Finally,  aortic aneurysm symptoms may not appear until the aneurysm becomes large or bursts. For this reason, patients should report any unusual fluoroquinolone side effects to their doctor immediately.

Fluoroquinolone Antibiotic Side Effects

Unfortunately, this is not the first time the FDA has issued an alert for fluoroquinolone antibiotics. In fact, the agency has updated the drugs’ labeling on multiple occasions to note the following risks:

  • Mental health issues
  • Severe blood sugar disturbances
  • Permanent damage to tendons, muscles, joints, nerves, and central nervous system.
  • Peripheral neuropathy.
  • Tendon injuries and tendon ruptures

Late last year, Janssen Pharmaceuticals announced it would stop manufacturing injectable and oral versions of Levaquin. However, the drugs will remain on the market until 2020.

Levaquin Lawsuits for Antibiotic Injuries & Complications

In recent years, thousands of people have filed personal injury lawsuits over side effects allegedly associated with Levaquin, Cipro, and Avelox.

In 2012, for example, Bloomberg reported that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary had settled hundreds of Levaquin tendon injury lawsuits

Peripheral neuropathy lawsuits involving Levaquin, Cipro, and Avelox are centralized in the U.S. District Court, District of Minnesota. (MDL No. 15-MD-2642)

Finally,  growing number of plaintiffs have filed legal claims for aortic dissections and aortic aneurysms allegedly caused by Levaquin and other fluoroquinolones.


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