In December 2018, the FDA added new warnings to fluoroquinolone antibiotics after receiving reports of rare but serious 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 death. These serious side effects were seen in patients who had been treated with systemic fluoroquinolones given by mouth or through an injection.
The risk appears to apply to both current and past users of fluoroquinolone antibiotics, with recent users having a roughly two-fold adjusted increased risk for an aortic aneurysm or dissection hospitalization, according to a study published in JAMA Internal Medicine.
What is an Aortic Aneurysm?
An aortic aneurysm is a bulging or ballooning in the wall of the aorta, which is the major artery carrying blood from the heart to other parts of the body. If an aneurysm grows large and stretches the artery too far, it can burst and cause dangerous bleeding or death. Aortic aneurysms can occur in the area below the stomach (abdominal aneurysm) or the chest (thoracic aneurysm).
What is an Aortic Dissection?
An aortic dissection is a tear in the wall of the aorta. As the tear extends along the wall of the aorta, blood can flow in between the layers of the blood vessel wall. This can lead to aortic rupture or decreased blood flow to the organs.
Fluoroquinolones are antibiotics that have much more serious side effects than what was known when they were first approved by the Food and Drug Administration (FDA) in 1987. They are a newer class of quinolone antibiotics and work by killing or stopping the growth of bacteria.
Fluoroquinolones antibacterial drugs are commonly used to treat and prevent a variety of diseases caused by bacteria, including lower respiratory tract infections, skin infections, urinary tract infections, inflammation of the prostate, sinusitis, and gonorrhea.
The FDA recommends that fluoroquinolones not be used in patients at an increased risk for aortic ruptures or tears of the aorta unless there are no other treatment options available. People at increased risk include those with a history of blockages or aneurysms of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.
The warning is based on four published observational studies as well as cases reported to the FDA, all of which provide consistent evidence that fluoroquinolones are associated with an aortic aneurysm or dissection. The risk has been estimated from nine aortic aneurysm events per 100,000 people per year in the general population to 300 aortic aneurysm events per 100,000 per year in individuals at the highest risk.
FDA-approved fluoroquinolones are available in tablets, capsules, injectables, ear drops, eye drops and inhalers.
- Avelox (moxifloxacin)
- Baxdela (delafloxacin)
- Cipro (ciprofloxacin)
- Factive (gemifloxacin)
- Floxin (ofloxacin)
- Levaquin (levofloxacin)
- Noroxin (norofloxacin)