Studies Mount Regarding Fluoroquinolones and Aortic Disease;
Vascular Surgeon Advises Against Use of Fluoroquinolones in Certain Patients
In a recent issue of the publication JAMA Surgery, a vascular surgeon advised against the use of fluoroquinolones in patients with aortic pathology or predisposition to an aortic aneurysm and dissection (AAD). The surgeon, Gilbert R. Upchurch Jr., M.D., makes this commentary in light of study results published in the same JAMA Surgery issue. In the study, researchers observed the effects of the drug ciprofloxacin on mice during the course of a year and found an increased risk of AAD progression, rupture, and death in certain mice that received the drug.
What Are Fluoroquinolones?
Fluoroquinolones are broad-spectrum antibiotics used to treat a variety of infections, namely respiratory infections, urinary tract infections, and abdominal infections. Ciprofloxacin is one of most common types of fluoroquinolones, along with levofloxacin and moxifloxacin.
These drugs have been on the market for decades, but recently, they have been linked to dangerous complications, prompting changes to the drug warning labels. Recently, manufacturers of fluoroquinolones were required to add warning information to their drug labels regarding the risks of tendinitis and tendon ruptures, peripheral neuropathy, and central nervous system effects associated with the use of the antibiotics. They added the new warning information using a “Black Box” warning, which is the strongest possible warning for a prescription drug.
Studies Link Fluoroquinolones to Aortic Aneurysm and Dissection
In addition to the risks encased in fluoroquinolone Black Box warnings, studies have emerged regarding the potential association between fluoroquinolones and aortic aneurysm and dissection. In a Swedish study, researchers documented an increased risk of AAD in patients who had been taking fluoroquinolones for 60 days. They found the association by studying hospital and emergency department admissions for AAD or related death in patients taking the antibiotics.
Another study, using data from Taiwan, also found an association between the antibiotics and an increased risk of AAD. This study went even further, however, and showed an association between increased risk of AAD and past use of fluoroquinolones.
Rather than analyzing patient data, the study in the JAMA Surgery publication observed the effects of fluoroquinolones in real time. The researchers involved in this study used an animal model and created certain groups that were predisposed to AAD. As part of the study, 86 mice were assigned to so-called “challenged” groups. These mice received a high-fat diet for eight weeks and subcutaneous angiotensin II infusion during the last four weeks. The researchers then administered ciprofloxacin to slightly more than half of the challenged mice (48) and saline to the remaining challenged mice.
In the test group of mice that received both the aortic challenges and the ciprofloxacin, researchers observed the following results:
- Aortic disease and dilatation in 47 of the mice (98 percent of the group)
- Severe AAD in 32 of the mice (67 percent)
- Aortic rupture and premature death in seven of the mice (15 percent)
In publishing their findings, the researchers said their results suggested that ciprofloxacin significantly increased 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 an aortic rupture, or die prematurely. 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.”
Symptoms and Complications of AAD
An aortic aneurysm is characterized by an enlargement or bulge in the aorta, which is the major blood vessel that distributes blood from the heart to the rest of the body. An aneurysm can occur in the abdominal aorta or the thoracic aorta. In rare cases, an aneurysm can occur in both segments at once.
Symptoms of an aortic aneurysm can include:
- Coughing or hoarseness
- Difficulty breathing
- Pain in the jaw or neck
- Pain in the back or chest
- Pain in the groin or abdomen
- Physical mass capable of being felt by a physician
Many patients with an aortic aneurysm will not experience definitive symptoms, which makes diagnosis difficult but no less urgent. If left untreated or if untimely treated, an aortic aneurysm can result in a rupture of the aorta or aortic dissection.
Aortic dissection occurs when a portion or layer of the aorta tears or separates from an outer layer. Aortic dissection is commonly precipitated by an aortic aneurysm, but this is not always the case.
Symptoms of aortic dissection include:
- Sudden, severe chest pain, back pain, or abdominal pain often accompanied by ripping or tearing sensation
- Loss of consciousness
- Difficulty breathing
- Stroke-like symptoms, including speech difficulties, vision loss, or facial drooping/paralysis
- Leg pain or leg paralysis
- Difficulty walking
Following an aortic dissection, blood will start to pool into the channel between the aortic layers, placing pressure on the aorta that can lead to a rupture. A rupture will cause serious internal bleeding that can be life-threatening without immediate medical attention.
Surgeon Warns Against Use of Fluoroquinolones in Certain Patients
In the same issue of JAMA Surgery in which the mouse model researchers published their findings, Dr. Gilbert Upchurch put the study into context and provided guidance for physicians moving forward. Dr. Upchurch, a vascular surgeon in the Department of Surgery at the University of Florida, Gainesville, pointed out that the mouse study had limitations. One of those limitations was the mere fact that the study used mice. Although human studies have not been conducted due to ethical concerns, there is a limit to the information the medical community can translate from rodents to humans.
In addition, the study focused exclusively on ciprofloxacin, which is only one kind of fluoroquinolone, and it did not look into the ways timing and dosage might affect the risk of AAD progression, rupture, and death. That said, Dr. Upchurch also urged physicians to pay attention to the study’s results and to change their prescribing practices with regard to at-risk patients.
“Clearly, the present animal study, in conjunction with multiple human observational studies, should give us pause when we consider using fluoroquinolones in patients with aortic dilatation and those at risk for AAD,” Upchurch said. “Stopping short of calling for a black-box warning, my recommendation would be to look for another antibiotic in patients with aortic pathology and consider avoiding this class of antibiotics in patients who are prone to AAD.”
Parker Waichman LLP: Experienced Drug Injury Attorneys
If you took a fluoroquinolone antibiotic, like ciprofloxacin, and developed AAD or aortic rupture, contact Parker Waichman LLP for a case consultation. Our experienced Fluoroquinolone Aortic Disease lawsuit attorneys offer free consultations and will assist you in understanding your legal options. You can reach our offices today by calling 1-800-YOURLAWYER (1-800-968-7529) or by filling out the Contact Form on our website.
