Aortic Aneurysm

Fluoroquinolone Antibiotics: Safety Communication – Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

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ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.  They work by killing or stopping the growth of bacteria that can cause illness.  Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).

RECOMMENDATION:
Healthcare professionals should:

  • Avoid prescribing fluoroquinolone antibiotics 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.
  • Prescribe fluoroquinolones to these patients only when no other treatment options are available.
  • Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.
  • Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should:

  • Seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.
  • Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.
  • Inform your health professional before starting an antibiotic prescription,  if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.
  • Not stop the antibiotic without first talking to your health care professional.

Fluoroquinolone Use Is Associated with Excess Risk for Aortic Aneurysm or Dissection

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A Swedish cohort study shows that oral fluoroquinolone is associated with higher risks than is amoxicillin.

Fluoroquinolones are associated with tendinopathy and tendon rupture (NEJM JW Gen Med Jan 1 2013 and Am J Med 2012; 125:1228.e23). The presumed mechanism is stimulation of matrix metalloproteinase activity, which results in degradation of collagen and extracellular matrix structural components. Because excessive metalloproteinase activity also is involved in the pathophysiology of aortic aneurysm, Swedish researchers performed a registry-based study to explore a possible association between fluoroquinolone use and aortic aneurysm or dissection. About 306,000 fluoroquinolone treatment episodes (78% ciprofloxacin) were propensity score–matched to the same number of amoxicillin treatment episodes in middle-aged or older adults (age, ≥50).

Within 60 days of the date that a prescription was filled, rates of aortic aneurysm or dissection were 1.2 cases per 1000 person-years for fluoroquinolone and 0.7 cases per 1000 person-years for amoxicillin — a significant difference. The estimated absolute difference was 82 cases of aortic aneurysm or dissection by 60 days per 1 million treatment episodes.

Comment

This large study, in which confounding was minimized through propensity-score matching, adds to a growing body of evidence that fluoroquinolone use is associated with excess risk for aortic aneurysm or dissection. The results are biologically plausible given the mechanisms discussed above.