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Fluoroquinolone Antibiotics Side Effects

People prescribed Fluoroquinolone antibiotics to treat infection may be at risk for developing aortic dissection, aortic aneurysm and tendon problems. The FDA required the manufacturers of these drugs to add a boxed warning to prescribing information.

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Patients who take antibiotics for certain types of bacterial infections should be aware of which medication they are taking and the potential dangers of experiencing fluoroquinolone side effects. Certain antibiotics may be associated with milder side effects, like head aches, or more serious complications, such as tendon rupture and heart problems.

Fluoroquinolone antibiotics are used to treat a variety of bacterial infections. Though their approved uses are different, oral and intravenous fluoroquinolone antibiotic indications include use against bacteria that cause respiratory and urinary tract infections, bacterial bronchitis, pneumonia, sinusitis, typhoid fever, septicemia, joint and bone infections, soft tissue and skin infections, bacterial gastroenteritis, and some sexually transmitted infections. 1

Others exist, such as lomefloxacin (Maxaquin) and sparfloxacin (Zagam). The brand name versions of these drugs are no longer available in the United States.

Common Fluoroquinolone Side Effects

In addition to the potentially life-threatening conditions of aortic dissection and aortic aneurysm that may occur with use of antibiotics, other less severe fluoruoquinolone side effects exist that may accompany use of these medications.

Quinolone antiobiotic side effects may include:

  • Headaches
  • Skin rash
  • Gastrointestinal problems
  • Allergic reactions 1

Other serious side effects of fluoroquinolone antibiotics may include:

  • Seizures
  • Hallucinations
  • Potential liver damage, kidney damage, or bone marrow damage
  • Angioedema
  • Photosensitivity
  • Peripheral neuropathy 2

Because other antibiotics may be able to treat the same indications as quinolone drugs, it is important that patients are aware of each drug’s benefits and the possible risk of aortic dissection and aortic aneurysm in patients taking oral fluoroquinolones.

Common Fluoroquinolone Antibiotics

Fluoroquinolone antibiotics available in the United States include:

  • Ciprofloxacin and its variations (Cipro, Cipro XR, and Proquin XR)

  • Gemifloxacin (Factive)

  • Levofloxacin (Levaquin)

  • Moxifloxacin (Avelox)

  • Norfloxacin (Noroxin)

  • Ofloxacin (Floxin)

Studies Link Quinolone Drugs to Aortic Problems

Two recent studies suggest that taking fluoroquinolone antibiotics may be associated with increased likelihood of suffering two potentially life-threatening conditions: aortic dissection or aortic aneurysm. 3 Although the medical community has been aware of an association between fluoroquinolone antibiotics and tendinitis and tendon rupture for several years, the studies evaluating such a link between fluoroquinolones and aortic dissection and aortic aneurysm were published recently.

According to researchers of the studies, “degradation” of type I and type III collagen seems to be associated not only with tendon weakening, but also with weakening of the aortic wall.  Use of fluoroquinolones was found to be associated with increased risk for aortic aneurysm or dissection. 3

Type I and type III collagen constitutes most of the collagen in tendons and the aorta. If aortic dissection or an aortic aneurysm occurs, the condition can be fatal. 3

No warnings, precautions or mention of aortic dissection or aortic aneurysm as potential fluoroquinolone side effects exist in any of these antibiotic labels.

Symptoms of Aortic Dissection

Untreated, the tear can lead to decreased blood flow to the body’s organs or an aortic rupture, or bursting. This condition can be fatal.

An aortic dissection “is a tear in the wall of the major artery carrying blood out of the heart (aorta).” Depending on the size of the tear, “blood can flow in between the layers of the blood vessel wall (dissection).” 4 Untreated, the tear can lead to decreased blood flow to the body’s organs or an aortic rupture, or bursting. This condition can be fatal. 4

Usually, symptoms begin suddenly. 4 They may include:

  • Severe chest pain that feels sharp, like a stabbing, tearing or ripping; the pain may seem to move or change position, from below the chest bone to under the shoulder blades, the back, neck, arm, jaw, abdomen or hips.
  • Anxiety
  • Fainting or dizziness
  • Heavy sweating
  • Nausea and vomiting
  • Rapid, weak pulse
  • Shortness of breath and trouble breathing when lying flat
  • Difficulty swallowing 4

Symptoms of Aortic Aneurysm

An aortic aneurysm is a weakened, bulging area of the aorta, the major blood vessel leading out of the heart. Aortic aneurysms can occur in the thoracic (upper) portion of the aorta, or the abdominal (lower) portion of the aorta. Abdominal aortic aneurysms are more common than thoracic aortic aneurysms. 5 Large, fast-growing aortic aneurysms may burst, or rupture. This condition can be fatal. 6

Symptoms vary depending on the size of the bulge, or weakening, of the aortic wall. A slow-growing, small aneurysm may not be noticeable and may be difficult to detect. 7 Some areas of weakness in the aortic wall may never rupture. Other times, the weakness in the aortic wall grows. Predicting if or when a rupture will occur is difficult. 7
Symptoms of a thoracic aortic aneurysm may include:

  • Chest tenderness or pain
  • Back pain
  • Cough
  • Shortness of breath
  • Hoarseness 8

Symptoms of an abdominal aortic aneurysm may include:

  • A pulsating feeling near the navel
  • Constant, deep pain in the abdomen
  • Back pain 9

The FDA and Fluoroquinolone Risks

In 2008, the U.S. Food and Drug Administration (FDA) concluded that fluoroquinolone antibiotics were associated with tendinitis and tendon rupture. At the time, the agency notified manufacturers of fluoroquinolone antibiotics of the need to “add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture…” 10

The FDA noted the risk “is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy.” The FDA cautioned that if patients taking fluoroquinolone antibiotics notice signs of tendon pain, swelling, or inflammation, they should stop taking the fluoroquinolone antibiotic, “avoid exercise and use of the affected area,” and contact their doctor right away. 10

  1. http://livertox.nih.gov/Fluoroquinolones.htm
  2. http://livertox.nih.gov/Fluoroquinolones.htm; http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm; http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm
  3. http://archinte.jamanetwork.com/article.aspx?articleid=2451282; http://bmjopen.bmj.com/content/5/11/e010077.full
  4. https://www.nlm.nih.gov/medlineplus/ency/article/000181.htm
  5. http://www.mayoclinic.org/diseases-conditions/thoracic-aortic-aneurysm/home/ovc-20122021; http://www.mayoclinic.org/diseases-conditions/abdominal-aortic-aneurysm/basics/definition/con-20023784
  6. http://www.mayoclinic.org/diseases-conditions/thoracic-aortic-aneurysm/home/ovc-20122021; http://www.mayoclinic.org/diseases-conditions/abdominal-aortic-aneurysm/basics/symptoms/con-20023784
  7. http://www.mayoclinic.org/diseases-conditions/thoracic-aortic-aneurysm/symptoms-causes/dxc-20122022; http://www.mayoclinic.org/diseases-conditions/abdominal-aortic-aneurysm/basics/symptoms/con-20023784
  8. http://www.mayoclinic.org/diseases-conditions/thoracic-aortic-aneurysm/symptoms-causes/dxc-20122022
  9. http://www.mayoclinic.org/diseases-conditions/abdominal-aortic-aneurysm/basics/definition/con-20023784
  10. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm