Risk of Acute Aortic Disease Linked to Levaquin, Avelox, Other Fluoroquinolone Antibiotics Confirmed in New Study

As a growing number of lawsuits over aortic dissection and aortic aneurysm injuries continue to be filed against the makers of Levaquin, Avelox and Cipro, new research appears to confirm the link between use of the controversial fluoroquinolone antibiotics and acute aortic disease.

In a study published last week in the medical journal The BMJ, researchers found a small but significant increase in the risk of aortic aneurysm or dissection among those who take a class of antibiotics known as fluoroquinolones.

According to the findings, most of that risk is associated with aortic aneurysms, which is a painful and potentially serious condition involving a bulge in the aorta, where the walls of the artery have weakened. This can cause severe chest pain, as well as carry the risk of rupturing.

Aortic dissections involve a similar, but potentially more serious and life-threatening condition, involving degradation within the layers of the aorta. Both pose a serious health risk and usually require invasive surgery to treat.

In this study, researchers conducted a nationwide historical cohort study in Sweden looking at data on patient characteristics, drug prescriptions, and cases of aortic aneurysm or dissection in Sweden from July 2006 to December 2013. The findings compared more than 360,000 cases of fluoroquinolone use, 78% of which was Cipro, with an equal number of cases of amoxicillin use.

According to the findings, there were 1.2 cases of aortic aneurysm or dissection for every 1,000 person years among those taking Cipro, Levaquin or Avelox. That compares to only 0.7 cases among those taking amoxicillin; an increased risk of 66%. When the researchers looked at the risk of aortic aneurysm alone, the risk was nearly double.

“Our study supports the notion that fluoroquinolone use could be associated with an increased risk of aortic aneurysm or dissection,” the researchers concluded. “Before these results are used to guide clinical decision making, the collective body of data on this safety issue should be scrutinised by drug regulatory authorities and weighed, together with other safety issues with this drug class, against the benefits of treatment; this will support appropriate clinical treatment recommendations.”

This is the third recent study to link the side effects of Levaquin, Avelox and Cipro to aortic aneurysms and dissections.

The most recent was a study by researchers from Baylor College, who conducted tests on mice using fluoroquinolone antibiotics and indicated they found that the drug appeared to increase the risk of aortic aneurysms or aortic dissections in mice with already stressed aortas. Healthy aortas appeared to be unaffected.

In October 2015, a report published in the medical journal JAMA Internal Medicine found that current use of Levaquin, Avelox or other similar fluoroquinolone antibiotics was associated with a two-fold increased risk of suffering an aortic aneurysm or dissection injury. The research was conducted to examine whether the known risk of collagen degredation from fluoroquinolones, which causes the risk of tendon ruptures, may also cause problems with the aorta.

The FDA issued a major fluoroquinolone antibiotics warning in May 2016, indicating that a variety of “disabling and potentially serious side effects” led the agency to conclude that the risks may outweigh the benefits associated with using the medications to treat uncomplicated infections. However, that warning focused on reports of permanent nerve damage, known as peripheral neuropathy, as well as tendon ruptures and other health risks, and the statement did not address concerns about the risk of aortic aneurysm and aortic dissection from the antibiotics, which emerged with the publication of an independent study months earlier.

In May 2017, the FDA issued another drug safety communication indicating that it found no link between Cipro and similar antibiotics and an increased risk of aortic aneurysm and aortic dissection. However, independent studies since then seem to contradict those findings..

There are currently hundreds of Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits pending throughout the federal court system, alleging that the drug makers failed to warn about potential side effects allegedly caused by the antibiotics.