Fluoroquinolone Antibiotics Aortic Aneurysms and Dissections

Fluoroquinolone Antibiotics Lawsuit

The FDA has warned that fluoroquinolone antibiotics like Cipro, Avelox, and Levaquin may double the risk of aortic aneurysm in certain patients. Manufacturers of these drugs may be facing a number of lawsuits for aortic injuries and other risks like tendon rupture.

Fluoroquinolone drugs that have been named in lawsuits include:

• • Cipro
  • Levaquin
  • Avelox
  • Factive
  • Maxaquin
  • Noroxin
  • Floxin

Fluoroquinolone Safety Alerts

The most recent safety alert regarding fluoroquinolones issued by the U.S. Food and Drug Administration (FDA) has warned that use of fluoroquinolone or “floxin” antibiotics can double the risk of a potentially fatal medical condition, aortic aneurysm.

Manufacturers of the drugs have already faced thousands of lawsuits for tendon rupture, aortic dissection and aneurysm, and other injuries, but may be facing an increased number of lawsuits for aortic aneurysm due to the new warning.

Fluoroquinolone Aortic Aneurysm

Fluoroquinolones have been shown to increase the risk of fatal cardiac complications including aortic aneurysm and aortic dissection. This likely occurs in the same way that tendon damage occurs due to disruption of collagen formation and cartilage destruction.

The aorta is the largest blood vessel in the circulatory system and carries oxygenated blood from the heart to the tissues. It is a rigid vessel which is formed and supported by collagen. When collagen is weakened, the aorta wall may thin and bulge or tear. 

Aortic aneurysm occurs when a bulge develops in the aorta. Aortic dissection occurs when a tear develops in the inner lining which then splits away from the middle layer. In either case, the aorta will rupture and cause a massive hemorrhage or blood loss, quickly resulting in death.

A recent study suggests that the increased aortic aneurysm risk begins right after taking the medication and may last as long as 60 days after discontinuing it. Though the overall threat for aortic aneurysm is low, it is three times higher than someone who has not taken a fluoroquinolone antibiotic. In some patients, the risks of using the antibiotics may be greater than any benefit and experts have warned that alternative therapy should be considered. 

Patients who are at greatest risk include those with a history of:

• elderly
• blocked blood vessels
• high blood pressure
• Marfan syndrome, Ehlers-Danos syndrome or other genetic conditions

Previously, fluoroquinolone manufacturers have been the subject of thousands of lawsuits for tendon injury and other collagen disorders. Many of these lawsuits were previously settled for undisclosed amounts. 

Fluoroquinolone Side Effects

Fluoroquinolone antibiotics work by inhibiting bacterial DNA formation and repair and preventing bacteria from dividing. They have been used to treat a wide variety of infections caused by bacteria. 

Most side effects of fluoroquinolones are mild to moderate including:

• Nausea and vomiting
• Headache
• Diarrhea 
• Itching
• Vaginitis

More severe side effects may include:

• Symptoms of allergic reaction including rash, facial swelling or difficulty breathing
• Watery diarrhea
• Changes in color of skin, urine, or stool 
• Swelling or fluid collection
• Changes in heart rhythm
• Tingling or unusual or sudden pain
• Confusion or unusual behavior
• Seizures
• Severe nervousness or anxiety
• Sudden dizziness or fainting

Severe side effects should be reported to a medical professional as soon as possible. Sudden changes or worsening condition may warrant emergency treatment.

Fluoroquinolone FDA Warning History

In 2008, the FDA issued a” black box warning” regarding the dangers of fluoroquinolones and tendon rupture. A black box warning is the strongest warning that can be issued by the agency and must be printed at the top of prescribing information.  Occurrence or worsening of symptoms of the neurological condition myasthenia gravis was added to the black box warning in 2011. In 2013, the agency required updates to include potential for irreversible peripheral neuropathy or permanent nerve damage.

In 2016, enhanced warnings about potentially disabling and permanent side effects affecting tendons, muscles, joints, nerves and the central nervous system were required. An FDA advisory committee subsequently recommended that fluoroquinolones not be used as first choice medications for uncomplicated urinary tract infections, sinus infections or bronchitis. It was also recommended that use be restricted in children. In 2016, prescribing information was changed to state that fluoroquinolones should be reserved for patients who were not treatable with other medications. Information about nerve damage was also added to the patient information guide.

In July 2018, the FDA updated warnings for fluoroquinolone antibiotics due to increased risks of mental health disorders and low blood sugar side effects. The agency required safety labeling changes which strengthened warnings and precautions to separate and highlight mental health effects by listing them separately from neurological warnings. In addition, language across all fluoroquinolones was standardized. Mental health side effects included agitation, nervousness, disorientation, disturbances in attention, memory impairment, and delirium.

In December of 2018, the FDA issued a new safety warning stating that fluoroquinolone use could double the risk of aortic aneurysm, and that the medication should not be used in sensitive populations who may be at greater risk for the condition. The agency recommended again that it be reserved for patients and infections that were not treatable with other medications.

Levaquin and Others Discontinued

Since introduction of the category, multiple fluoroquinolones have been discontinued or withdrawn from the market due to toxicity or as business decisions due to potential side effect risks. Factive/Gemifloxacin (Vansen Pharma), Maxaquin/lomefloxacin (Searle), Raxar/grepafloxacin (Glaxo Wellcome) and Zagam/sparfloxacin (Rhone-Poulenc Rorer) are no longer available in the United States. Merck discontinued its fluoroquinolone drug Noroxin/norfloxacin in 2014.

In 2019, Janssen/Johnson & Johnson officially declared that it would stop making Levaquin/levofloxacin and Floxin/ofloxacin. The company stated that it was not recalling its medication and that existing supplies of Levaquin would remain on shelves until sold or expired, but that no more of the medication would be made after 2020.

Cipro/ciprofloxacin continues to be manufactured by Bayer and multiple generic drug companies while Avelox is only available as a generic medication.

Fluoroquinolone Lawsuit Settlements

Manufacturers of quinolone antibiotics like Levaquin, Cipro, and Avelox, have faced thousands of lawsuits for injuries caused by their medications. Many of these lawsuits were settled in previous years, but new lawsuits have continued to be filed.

At least one aortic aneurysm lawsuit has resulted in a $700,000 jury verdict for the victim, but many may remain in federal, state and local courts.

*Prior results do not guarantee or predict a similar outcome with respect to any future matter.