Fluoroquinolones Complications: The Cipro®, Avelox®, and Levaquin® Lawsuit

Fluoroquinolones and Indications for Use

Levaquin®, Avelox®, and Cipro® belong to a class of broad-spectrum antibiotics called fluoroquinolones. Among the most prescribed medications in the world, fluoroquinolones are used to effectively treat a variety of bacterial infections, including:

• Urinary tract infections
• Gastrointestinal infections
• Bone and joint infections
• Respiratory infections
• Sexually transmitted infections
• Skin and soft tissue infections
• Osteomyelitis
• Bacteremia

Additionally, fluoroquinolones can be especially useful for treating hospital-acquired infections and other infections that have become resistant to older antibiotic treatments. Many researchers have also noted that these medications have been overprescribed for minor health problems like ear and sinus infections since they were released to market.

Pharmaceutical companies have an obligation to produce safe and effective drugs that are thoroughly tested before being marketed to the public.

Fluoroquinolones consist of an antibiotic medication that has had a fluoride molecule added to it to increase the drug’s ability to penetrate different types of tissue. This mechanism is precisely what gives this class of medication the ability to treat different types of infection, but is also the reason that many patients have experienced harmful complications. Studies conducted on animals show that fluoride is directly toxic to collagen production and can promote a degradation of collagen structures.

Claims Filed in the Fluoroquinolones Lawsuit

Many patients have already filed claims against the manufacturers after being prescribed Cipro®, Avelox®, or Levaquin® and experiencing complications. These lawsuits allege misconduct on the part of the manufacturer to intentionally conceal the dangers associated with their products or improper testing methods to determine their safety.

Negligence

Pharmaceutical companies have an obligation to produce safe and effective drugs that are thoroughly tested before being marketed to the public. Lawsuits allege that the manufacturers of fluoroquinolone medications failed to meet this obligation due to inadequate testing or labeling.

Failure to Warn

Drug companies are also expected to fully disclose the possibility of any complications or side effects associated with their products. However, in the case of Cipro®, Avelox®, and Levaquin®, the manufacturers failed to warn both healthcare practitioners and patients about any possible dangers until the U.S. Food and Drug Administration (FDA) updated their safety recommendations and required new labeling.

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Strict Liability

Claims also allege that the manufacturers were fully aware of the inherent dangers of possible complications associated with their products, but failed to disclose that information to the general public.

Fraud

These lawsuits claim that the drug companies intentionally misrepresented the safety of these medications in order to conceal the danger of peripheral neuropathy and aortic dissection associated with Avelox®, Levaquin®, and Cipro®.

Complications and Side Effects of Fluoroquinolone Use

The use of Cipro®, Avelox®, and Levaquin® has been found to produce various short-term side effects in some patients, including:

• Skin rash
• Headaches
• Stomach discomfort
• Seizures
• Hallucinations
• Heart arrhythmia
• Angioedema

In addition to these somewhat common side effects, many patients have also experienced more troubling complications after being prescribed fluoroquinolones. Even patients who were only prescribed the medication once have developed permanent damage that may have been caused by Cipro®, Avelox®, or Levaquin®.

Peripheral Neuropathy

One of the most serious complications of fluoroquinolone use is peripheral neuropathy. This condition occurs when the nerves of the peripheral system become damaged and begin confusing messages and sensations that are normally sent along these channels. Many patients will experience pain in response to sensations that should not be painful, or will lose feeling in their fingers and toes. Symptoms of peripheral neuropathy may include:

• Excessive sweating or lack of sweating
• Digestive problems
• Poor bowel control
• Sexual dysfunction
• Muscle deterioration
• Paralysis
• Burning or tingling sensation

Peripheral neuropathy is not typically fatal, but the condition can cause a lifetime of suffering for affected patients and may require extensive treatments using opioid painkillers and antidepressants to combat all of their symptoms.

Aortic Dissection and Aneurysm

The aorta carries blood away from the heart and delivers it to the rest of the body. Researchers suspect that fluoroquinolones interact with collagen in the lining of the aorta and weaken the structure of the vessel. This weakening allows for dissection (tearing) and aneurysm (rupture) of the aorta. Damage to this vessel can cause several additional complications, including strokes, heart attacks, organ failure, and death. Numerous studies published in various medical journals have found that patients taking fluoroquinolones are at nearly double the risk for aortic dissection and almost three times as likely to rupture the vessel.

Tendon Rupture

Fluoroquinolones can also interact and weaken collagen structures in muscles and tendons. As of July 8, 2008, the FDA has required a “black box” warning of tendon rupture to all fluoroquinolone medication labels. This is the strongest warning that the FDA can require for a medication.

Claims also allege that the manufacturers were fully aware of the inherent dangers of possible complications associated with their products, but failed to disclose that information to the general public.

Ruptures of the Achilles tendon are the most prevalent form of injury associated with fluoroquinolone use. Patients have also been diagnosed with rotator cuff injuries in the shoulder, as well as ruptures to tendons in the upper arm, hand, and thumb.

Journal Articles and FDA Warnings Concerning Fluoroquinolones

• On July 8, 2008, the FDA began requiring a “black box” warning on all packaging for fluoroquinolone medications. This was intended to make both patients and doctors fully aware of the risk of tendinitis and tendon rupture that has been associated with these medications. Additionally, the warning includes verbiage about conditions that will further increase a patient’s risk of developing tendon complications.
• On August 15, 2013, the FDA issued a safety announcement concerning fluoroquinolone medications and their risk of peripheral neuropathy. The agency made recommendations to update the safety warnings on all packaging for these drugs, including information about the serious side effect of peripheral neuropathy and that the damage may be permanent. The announcement also includes information about symptoms of neuropathy and instructs patients to discontinue use of fluoroquinolones if they experience any signs or symptoms.
• An article published in August 2014 in the journal Neurology® described a case-control study in which researchers endeavored to quantify the risk of peripheral neuropathy with oral fluoroquinolone use. The study followed men between the ages of 45 and 80 years old over a ten-year period, and identified over 6,000 cases of peripheral neuropathy and over 24,000 control subjects. Their findings show that patients taking fluoroquinolone medications are nearly twice as likely as subjects who were not taking the drug to develop peripheral neuropathy.

Schedule a Complimentary Case Evaluation

If you have been prescribed Levaquin®, Avelox®. or Cipro® and experienced any adverse complications, please contact an experienced defective products attorney who can evaluate your claim. Our attorneys have successfully taken on large pharmaceutical companies to protect our clients’ best interests and secure the damages they deserve. For current information on the case, please visit the current status of the fluoroquinolones lawsuit.