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


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.

Can We Predict the Site of Entry Tear by Computed Tomography in Patients With Acute Type A Aortic Dissection?


In patients with acute type A aortic dissection (AAD), localization of the primary entry tear to be excluded is of major importance for intervention.

Hypothesis:

There are reliable indirect computed tomography (CT) findings to predict the entry site.

Methods:

In 83 patients with type A AAD whose primary entry tears were identified surgically between 2003 and 2009, we retrospectively examined the diagnostic CT scans regarding pericardial effusion, the largest short-axial diameter of the aorta, widths of true and false lumens, and false lumen thrombosis at 6 levels of thoracic aorta from the aortic root to the descending aorta.

Results:

The primary entry sites identified intraoperatively were proximal ascending in 21 patients, middle ascending in 21, distal ascending in 21, arch in 17, and descending or unknown in 16. The multivariate logistic analysis revealed that pericardial effusion (odds ratio [OR]: 2.2, 95% confidence interval [CI]: 1.2–3.4, P < 0.001) and dilated ascending aorta (OR: 1.6, 95% CI: 1.1–2.4, P = 0.012) were the significant CT findings to predict the entry tear in the ascending aorta. It also revealed that the significant CT finding to predict the entry tear distal to the aortic arch was nonthrombosed false lumen in the descending aorta (OR: 1.2, 95% CI: 1.1–2.1, P = 0.048).

Conclusions:

We can predict the primary entry site by the preoperative CT findings in patients with type A AAD, considering pericardial effusion, aortic diameter, widths of true and false lumens, and false lumen thrombosis at different anatomic levels.

Source: http://onlinelibrary.wiley.com