Fluoroquinolone Antibiotics

Fluoroquinolone antibiotics like Cipro, Avelox and Levaquin are used to treat many different types of infections, but they may also cause life-threatening side effects like aortic aneurysm or aortic dissection.

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Aortic Aneurysm & Dissection Risks

Fluoroquinolone Antibiotics

Fluoroquinolone antibiotics, sometimes called “quinolones” or “floxins” have been used to treat a wide range of infections caused by bacteria. Because of recent safety information, use of fluoroquinolones should be restricted to infections which don’t respond to other medications and should be limited in sensitive populations including children and the elderly.

Fluoroquinolone medications approved in the U.S. include:

  • Levaquin (levofloxacin)
  • Cipro (ciprofloxacin)
  • Avelox (moxifloxacin)
  • Factive (gemifloxacin)
  • Floxin (ofloxacin)
  • Noroxin (norfloxacin)

The fluoroquinolones were discovered accidentally and were some of the first antibiotics available to treat gram (-) infections. Though researchers have created thousands of analogs, many were found to be too toxic to use. Some fluoroquinolones were introduced to the market but had to be withdrawn and only a few are currently available for use.

Because of possible harmful effects on the heart, tendons, and nerves, the FDA has said quinolones should not be the first choice for treatment of common illnesses.

Some of the uses of fluoroquinolones have included:

  • Urinary tract infection
  • Sinusitis
  • Pneumonia
  • Bronchitis
  • Skin and soft tissue infection
  • Sexually transmitted infection
  • Bone and joint infection
  • Infectious diarrhea
  • Hospital-acquired infections

Fluoroquinolone Side Effects

Like all medications, fluoroquinolones may cause side effects, most of which are mild to moderate but others may be more severe.

Common side effects may include:

  • Nausea and vomiting
  • Headache
  • Itching
  • Vaginitis

Side effects which may be more serious include:

  • Allergic symptoms of rash, itching, facial swelling or difficulty breathing
  • Watery diarrhea
  • Tingling or unusual pain
  • Changes in skin, urine or stool color
  • Fast or pounding heartbeat
  • Severe headache, dizziness or fainting
  • Severe nervousness or anxiety
  • Hallucinations, confusion, or unusual behavior
  • Seizures
  • Sudden pain or popping
  • Swelling or fluid collection

Any of these symptoms may be serious and should be reported immediately.

Aortic Dissection and Aortic Aneurysm

The U.S. Food and Drug Administration issued a December 2018 warning stating that fluoroquinolones have been associated with an increased risk of fatal cardiac complications including aortic aneurysm and aortic dissection. The agency states that the risk of aortic aneurysm may increase by two times, beginning immediately after the medications are started and continuing for up to 60 days after the medications are discontinued.

Certain risk factors will increase the chance of aortic aneurysm including:

  • elderly
  • history of blocked blood vessels
  • high blood pressure
  • genetic conditions which affect collagen formation including Marfans syndrome and others

This follows after two studies, published in 2015 in BMJ (British Medical Journal) and JAMA (Journal of the American Medical Association) indicate that the drugs may damage cartilage in the aorta, the same way they cause tendons to rupture. The aorta is the large vessel which brings blood to the heart to be pumped to the body. It gets its structure from the same type of collagen that makes up cartilage in the Achilles and other tendons and may be weakened in the same way.

Aortic aneurysm occurs when the aorta wall begins to thin and bulge and if ruptured, massive bleeding will occur. Aortic dissection occurs when the inner layer of the aorta develops a tear. Blood may enter and separate, or “dissect”, the inner and middle layer and may burst the vessel in the same manner. In either case, a ruptured aorta may quickly result in death.

Fluoroquinolone FDA Warnings

Studies indicated that fluoroquinolones are toxic to collagen I, which makes up most of the cartilage in large tendons. The drugs weaken collagen through “chelation”, by encouraging minerals such as calcium, magnesium or aluminum to stick to the cells. They may also interfere with cartilage repair by inhibiting enzymes or killing some of the cells needed to make new cartilage, known as chondrocytes.

Tendinopathy or tendon rupture risk may increase within days or even hours of taking a fluoroquinolone antibiotic and may be 3 or 4 times higher than normal. The risk is also higher in those over 60, organ transplant patients, or those taking anti-inflammatory steroids like prednisone. Fluoroquinolones should not be used in children unless medically necessary.

In 2008, the U.S. Food and Drug Administration issued a” black box warning” regarding the dangers of fluoroquinolones and tendon rupture. The FDA began requiring that manufacturers print information about the risk of tendon damage in a “black box” at the top of prescribing information for all fluoroquinolones. A black box statement is the most severe warning that can be given about a prescription medication. Manufacturers were also required to create a patient information guide about the risks.

In 2015, an FDA advisory committee was called to evaluate the usage of fluoroquinolones in routine treatment of simple infections. The committee reviewed reports of tendon rupture, nerve damage, and cardiac events associated with fluoroquinolone use and determined that medications should not be used as a first choice for uncomplicated urinary tract infections, sinusitis and bronchitis.

In June 2016, prescribing information for all fluoroquinolones was changed to state that the medications should not be used if other treatments were available and to discontinue use if serious side effects occurred. Information about nerve damage or neuropathy was also added to the patient medication guide.

Fluoroquinolone Lawsuit Information

In past years, many fluoroquinolone lawsuits for tendon injuries and other serious side effects were settled but the newest safety warning indicates that additional lawsuits may be expected for aortic aneurysm.

Read more about Fluoroquinolone Aortic Aneurysm lawsuits.

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