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Fluoroquinolones Linked to Aortic Aneurysm and Dissection;  Study Observes Increased Risk of AAD in Mice

In a recent issue of the publication JAMA Surgery, researchers described a year-long study in which they observed the effects of the drug ciprofloxacin on mice. They found that administration of ciprofloxacin increased the risk of an aortic aneurysm and dissection (AAD), rupture, and death in mice that were predisposed to AAD. While the results of the study do not definitively establish a cause-and-effect scenario, the authors found an “alarming association” between ciprofloxacin and AAD progression and rupture.

Ciprofloxacin Mice Model Study Methods

An aortic aneurysm is characterized by an enlargement of a segment of the aorta. Aortic dissection is a condition in which an enlarged aorta tears. Together, the two are known in the medical field as AAD. In the last several years, some literature has suggested a potential link between AAD and the use of certain popular antibiotics, called fluoroquinolones. With human studies unlikely because of ethical concerns, researchers have turned to animal models to gain an expanded understanding of the ways fluoroquinolones affect aortic health.

In an attempt to examine the effect of ciprofloxacin (a common fluoroquinolone also known as “Cipro”) on AAD development in mice, researchers randomly assigned 67 male mice and 59 female mice to one of four groups. The treatment the mice received during the study depended on their group. The study ran from October 2016 to September 2017, after which the researchers observed and analyzed the changes to the aortas of the mice in all the groups.

“Challenged” Mice Groups

Eighty-six mice were assigned to “challenged” groups. These mice received a high-fat diet for eight weeks and subcutaneous angiotensin II infusion during the last four weeks. The two challenges were designed to predispose the mice, in a way, to the development of AAD. The researchers then administered ciprofloxacin to slightly more than half of the challenged mice (48) and vehicle (saline) to the remaining challenged mice.

“Unchallenged” Mice Groups

Forty mice in the study were assigned to “unchallenged” groups. These mice were not exposed to the same predisposition challenges as the other mice; They received a normal chow diet and saline infusions, instead of angiotensin II infusions, during the last four weeks. Half of the unchallenged mice (20) then received ciprofloxacin, while the other half received the vehicle.

The study authors note that the experiments were approved by the Institutional Animal Care and Use Committee at the Baylor College of Medicine in accordance with the guidelines of the National Institutes of Health.

Results Show Link Between Cipro and AAD Progression

In analyzing the results of the study, the researchers found an association between the administration of ciprofloxacin and AAD progression, rupture, and premature death. They noted the following results across the groups:

Unchallenged Mice

• Without ciprofloxacin:
  1. No aortic destruction
  2. No aortic enlargement
  3. No AAD spontaneous formation
  4. No rupture
  5. No premature death
• With ciprofloxacin:
  1. No aortic destruction
  2. No aortic enlargement
  3. No AAD spontaneous formation
  4. Aortic dilatation observed in 4 mice (20 percent)
  5. No rupture
  6. No premature death

Challenged Mice

• Without ciprofloxacin:
  1. Aortic enlargement observed (number of mice not provided)
  2. Aortic dilatation observed in 27 mice (71 percent)
  3. AAD formation observed in 17 mice (45 percent)
  4. Severe AAD observed in nine mice (24 percent)
  5. No rupture
  6. No premature death
• With ciprofloxacin:
  1. Aortic enlargement observed (number of mice not provided)
  2. Aortic disease and dilatation observed in 47 mice (98 percent)
  3. Severe AAD observed in 32 mice (67 percent)
  4. Aortic rupture and premature death observed in seven mice (15 percent)

The findings, the study authors wrote, suggest that ciprofloxacin significantly increases susceptibility to aortic aneurysm progression, dissection, and rupture in mice under aortic challenge. In other words, when mice are already likely to develop AAD or already have AAD, administration of ciprofloxacin makes it more likely that they will develop severe AAD, experience a rupture, or die prematurely.

Because of the control groups, the researchers were able to determine that ciprofloxacin likely does not cause the spontaneous development of AAD, but rather contributes to its development and progression in mice already at risk. In conclusion, the authors said their findings “support concerns raised in observational studies regarding fluoroquinolone use and suggest that this drug should be used with caution in patients with aortic dilatation and those at high risk for AAD.”

Will the Study Lead to Drug Label Changes?

In May 2017, the U.S. Food and Drug Administration issued a Safety Communication regarding emerging studies on fluoroquinolones and AAD. In the communication, the FDA stated that patient cases and published studies available to date “ not support reports that these medicines may result in … bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection.”

The FDA noted that it would continue to assess safety issues regarding fluoroquinolones and would update the public if additional action was required. Could the results of this recent study prompt additional action by the FDA?

At this point, it is not clear. The FDA typically waits for a breadth of information or inarguable evidence about a safety issue to take meaningful action. The authors of the latest mice model acknowledge that their study has some limitations — namely that it only studied ciprofloxacin, as opposed to several types of fluoroquinolones, and that it did not measure effects of dosage or timing — and said further studies are warranted. Given that, the FDA could reasonably wait for additional studies before changing its position on the link between fluoroquinolones (or ciprofloxacin specifically) and AAD.

Any later action will likely take the form of a safety alert and a possible change to the drug labels associated with fluoroquinolones. A label change would require the drug manufacturers to place information about AAD in the warnings sections of their drugs’ prescription labels. Because of the popularity and effectiveness of fluoroquinolones in treating a variety of infections, it is not likely that the drugs will be recalled any time soon.

Contact Parker Waichman LLP for a Free Case Consultation

If you have or a loved one has developed AAD, severe AAD, or rupture after taking ciprofloxacin or another fluoroquinolone antibiotic, contact the Fluoroquinolone aortic aneurysm dissection lawsuit attorneys at Parker Waichman LLP to see if you could be eligible to file a lawsuit against the manufacturer. Our law firm is known for its prescription drug case results, and our lawyers offer free consultations to all new clients.

We understand in the face of injuries from a prescription drug, you are looking for answers and for someone to fight for you. We will perform a complete investigation of your potential claim to timely provide you with the information you need to make important decisions for yourself and your family. Our Aortic Aneurysm Dissection lawyers are honored to take on the fight for justice on behalf of injured people and families across the country.

Take advantage of our free Aortic Aneurysm Dissection case review offer today by calling 1-800-YOURLAWYER (1-800-968-7529) or by filling out the Contact Form on our website. We are available day and night and are prepared to begin working on your case today.