In December 2018, the Food and Drug Administration (FDA) added new warnings to fluoroquinolone antibiotics after receiving reports of patients suffering ruptures or tears in their aorta after use. The aortic dissections — also called ruptures of an aortic aneurysm — can cause severe internal hemorrhaging and death.
The serious side effects were seen in patients who had been treated with systemic fluoroquinolones, administered orally 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 the Journal of the American Medical Association (JAMA) Internal Medicine.
The FDA has recommended to medical providers that fluoroquinolones not be prescribed or provided to patients who are known to have an increased risk for aortic tears. Only when there is no other treatment option possible should fluoroquinolones be used.
Your doctor may diagnose you with an increased risk of aortic dissection if you have:
- High blood pressure (hypertension)
- Medical history of aortic blockages
- Suffered an aneurysm in the past
- Genetic disorders that may alter your cardiovascular system
- Weakened health due to elderly age
The FDA 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. It is estimated nine people in 100,000 could be at risk under normal circumstances. Given increased risk factors, the risk estimate spikes to 300 people per 100,000.
What are Fluoroquinolones?
Fluoroquinolones are antibiotics that have much more serious side effects than what was known when they were first approved by the FDA in 1987. They are a newer class of quinolone antibiotics and work by killing or stopping the growth of bacteria.
Fluoroquinolone 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.
Brand-Name Fluoroquinolones You May Have Taken
FDA-approved fluoroquinolones are available in tablets, capsules, injectables, ear drops, eye drops, and inhalers. You may have been prescribed one such medicine if you were diagnosed with a bacterial infection or illness.
Brand names of fluoroquinolones:
- Avelox (moxifloxacin)
- Baxdela (delafloxacin)
- Cipro (ciprofloxacin)
- Factive (gemifloxacin)
- Floxin (ofloxacin)
- Levaquin (levofloxacin)
- Noroxin (norofloxacin)
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.
What Can I Do If I Took a Fluoroquinolone Antibiotic?
If you or someone you love has suffered an aortic dissection or aortic aneurysm after taking a brand-name fluoroquinolone antibiotic, you may have a claim against the drug’s manufacturer. FDA-approved fluoroquinolones include Avelox, Baxdela, Cipro, Factive, Floxin, Levaquin and Noroxin. Remember: Never stop taking prescribed medication without first consulting your trusted medical provider.
Contact a dangerous drug attorney from Hutton & Hutton in Witchia for a free evaluation of your claim. Start by filling out a contact form, or by calling us at (316) 688-1166.