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Cipro – Aortic Aneurysm or Dissection

Cipro is an antibiotic which was once used to treat a wide variety of infections but is now restricted to serious infections and used mainly in adults because of potentially life-threatening cardiac side effects.

Cipro (ciprofloxacin)

Cipro (ciprofloxacin) is a fluoroquinolone-type antibiotic used to treat a variety of infections. Due to a risk of severe side effects, Cipro use is now limited to serious infections and infections which cannot be treated with other medicine.

Manufacturing information

Brand NameCipro
Generic Nameciprofloxacin
Classification Fluoroquinolone antibiotic
ManufacturerBayer
Dosage form(s)100mg tablet
250mg tablet
500mg tablet
750mg tablet
500mg XR tablet
1000mg XR tablet
250mg/5ml oral suspension
500mg/5ml oral suspension
200mg/100ml solution for IV infusion
200mg/20ml bulk solution for injection
400mg/40ml bulk solution for injection

Normal dosage Dose according to infection type, age, kidney status, and weight varies from single dose to up to 6 weeks of treatment

Cipro FDA Warnings

In 2008, the U.S. Food and Drug Administration (FDA) issued a black box or boxed statement warning about Cipro and other fluoroquinolones. The black box warning is the most serious warning that is issued by the FDA and must be printed at the top of all prescribing information enclosed in a box with a thick, black border.

Cipro’s 2008 boxed statement warned of the risk of tendinitis and tendon rupture in some patients. The risk of tendon rupture is greatest in patients who are over the age of 60, taking corticosteroid medications or who are organ transplant patients. In addition, the warnings state that people who have certain conditions that weaken muscles, such as myasthenia gravis, may experience a worsening of the symptoms and should not take Cipro.

Since the first warning was issued in 2008, the boxed statement for Cipro has been updated several times and now includes warnings about:

  • Tendon rupture
  • Peripheral nerve damage
  • Central nervous system damage
  • Allergic reaction

The label also states that the medication should be reserved for use in serious infections and cases where other medications do not work or cannot be used. Cipro use is not recommended for children and should only be used if medically necessary.

Most recently, concerns have been raised about evidence that shows the medication may cause rupture or tearing of the aorta as aortic aneurysm or aortic dissection which may result in severe hemorrhage and death. This information has not yet been added to the black box warning but it may be expected.

How does Cipro Work?

Cipro works by inhibiting enzymes that are used in bacterial DNA synthesis, repair and recombination. Inhibiting DNA production and repair will prevent bacteria reproduction and will prevent bacteria from repairing cell membranes, leading to cell death.

Cipro was once used for a wide range of infections in children and adults but is now limited to serious infections including:

  • Complicated urinary infection
  • Complicated skin and structure infections
  • Acute pyelonephritis
  • Nosocomial or community-acquired pneumonia
  • Chronic prostate infection
  • Anthrax exposure
  • Plague

Cipro may also be used for less serious infections when there are no other treatment options including:

  • Uncomplicated urinary tract infection
  • Acute bacterial sinusitis
  • Acute bacterial exacerbation of chronic bronchitis

Use of Cipro is not recommended for children unless medically necessary.

Cipro Side Effects

  • All medications may have side effects. Most side effects of Cipro are mild to moderate but others may be more severe and pose serious risks which may be life threatening.Nausea and vomiting
  • Diarrhea or constipation
  • Headache
  • Itching
  • Vaginitis

Serious side effects of Cipro:

  • Tendon rupture or damage
  • Peripheral nerve damage
  • Central nervous system effects
  • Anaphylaxis or severe allergic reaction
  • Aortic aneurysm or dissection

Symptoms of serious side effects including sudden pain in arms, legs or muscles, abdominal pain, chest pain, difficulty breathing or any changes in consciousness should be reported to a healthcare professional immediately.

Cipro Aortic Aneurysm or Aortic Dissection

Cipro may interfere with collagen structure which may cause cartilage to become brittle and tear. This is the mechanism by which tendon rupture occurs but may also cause serious cardiac effects that may be deadly.

Cipro and other fluoroquinolones weakening of collagen may lead to bulge or rupture in the rigid structure of the aorta, the largest blood vessel in the body. When the wall of the aorta bulges or separates, it may tear and quickly result in massive hemorrhage and death.

The FDA issued a December 2018 warning regarding the increased risk for cardiac side effects such as aortic aneurysm or aortic dissection. The increased risk may begin immediately after Cipro is first started and may continue for up to 60 days after the medication is discontinued.

Certain patients are more at risk for aortic injuries including:

  • Elderly
  • High blood pressure
  • Collagen disorder

Cipro’s use is also restricted or limited in children due to effects on collagen which may more adversely affect growing children.

Some medications in the floxin or fluoroquinolone group were recalled from the market due to toxicity. In 2018, manufacturers indicated that they would discontinue making Levaquin (levofloxacin) but have not recalled existing supplies. Bayer has not indicated a plan to discontinue Cipro.

Cipro Lawsuit

Bayer is facing a number of drug injury lawsuits for side effects caused by Cipro. Federal Cipro lawsuits have been consolidated with similar fluoroquinolone lawsuits into multidistrict litigation (MDL) in the U.S. District Court for the District of Minnesota, but more cases may exist in state and local courts.

People or loved ones of those who suffered from serious cardiac injury, tendon rupture or nerve damage after using Cipro, should seek legal assistance.

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