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Fluoroquinolone Antibiotics (FLQ)

 

Fluoroquinolone Antibiotics and Peripheral Neuropathy, Nerve Damage & Aortic Dissection

Have you or a loved one ever used Cipro, Levaquin, or Avelox? Were you or a loved one later diagnosed with peripheral neuropathy, other severe nerve damage or aortic dissection? If so, you may be entitled to financial compensation for your injuries.

What are Fluoroquinolone Antibiotics (FLQs)?

The FDA granted approval to the first FLQ, Noroxin, in 1986. Since then, others like Cipro, Levaquin and Avelox have been approved for use, typically in treating respiratory infections, sinus infections and urinary tract infections (UTIs). FLQs are what are known as broad-spectrum antibiotics that work on both gram-negative and gram-positive bacteria. The difference between the two types of bacteria is the thickness of their cell walls (gram-negative bacteria have thinner cell walls and lack the techoic acid component found in gram-positive bacteria).

FLQs are some of the most popular - and dangerous - antibiotics currently on the market. The FDA has approved FLQs for treating the following conditions:

  • Plague
  • Inhalational anthrax, post-exposure
  • Sinusitis
  • UTIs

They are also the most over-promoted and misused antibiotics on the market. Many studies have shown that between 30% and 70% of all fluoroquinolone prescriptions are unnecessary and contrary to established prescribing guidelines. This means that FLQs are often prescribed for conditions that don’t require this powerful an antibiotic.

Not only are FLQs over-prescribed, they aren’t necessarily the most effective drugs available.

  • More than one-third of FLQ prescriptions are for sinusitis, mild bronchitis, or uncomplicated UTIs
  • An FDA joint advisory committee recently voted 59 to 3 in favor of revising the current label to better address risk-benefit analysis in light of questionable efficacy
  • Antibiotic treatment showed no beneficial effect compared to placebo in 70 percent of sinusitis studies and 67 percent of bronchitis studies; for uncomplicated UTI, ibuprofen has been shown to be just as effective as antibiotics in treating symptoms.

We are helping those who have been injured by FLQs, specifically Avelox (moxifloxacin), Cipro (ciprofloxacin) and Levaquin (levofloxacin).

Highlighting just how often FLQs are used, over 26 million American patients are prescribed FLQs such as Avelox, Cipro or Levaquin every year.

What is the Problem with FLQs?

These powerful antibiotics have been linked to a number of serious complications, including peripheral neuropathy (nerve pain in the extremities), nerve damage, aortic aneurysms (bulges in the aorta, the largest blood vessel in the body) or aortic dissections (tears in the aorta). Aortic damage may cause heart attacks, strokes and even death.

Some published case reports document injuries such as:

  • “A 57-year-old Caucasian female . . . was treated for UTI with a ciprofloxacin regimen of 250 mg twice a day for 5 days . . . She presented 2 months later reporting whole body burning and alopecia. The burning, she claimed, started 2 or 3 days after completion of the prescribed course of ciprofloxacin. The burning lasted 3 weeks and resolved only to recur, unrelentingly, 3 weeks later . . . Two years after the initial onset of symptoms, the patient continues to suffer from polyneuropathies chronologically related to ciprofloxacin use. At her most recent visit, she describes constant pain of 7/10 and is unable, she states, to ambulate for more than 2 minutes, without intense shooting pains up and down her lower extremities.”
  • “A case series of 27 patients with suspected quinolone neurotoxicity [presented]:
    • Paraesthesia of the feet, legs, hands or arms (81 percent)
    • Numbness or hypoaesthesia (51 percent)
    • Pain or hyperaesthesia (27 percent)
    • Muscle weakness (11 percent)”

Aortic Damage

Among the most serious injuries caused by FLQs are aortic dissection and aneurysm. Aortic dissection, a tear in the aortic wall, allows blood to access layers of surrounding tissue. This build-up can cause heart attack, stroke and paralysis.

Aortic aneurysm, a bulge in the aortic wall that is subject to bursting, can be a silent killer. People with aortic aneurysms often present no symptoms until it is too late and the aneurysm bursts. The bursting causes excruciating pain followed by loss of consciousness. A burst aortic aneurysm leaves the patient with a 50% chance of survival.

Possible symptoms of aortic aneurysm include:

  • A pulsating feeling near the navel
  • Deep constant pain in your abdomen or on the side of your abdomen
  • Back pain

Both conditions require surgical intervention, medications and expensive lifetime monitoring.

Nerve Damage/Peripheral Neuropathy

Studies also show that FLQs are linked to a type of permanent nerve damage called peripheral neuropathy. This is a condition in which the nerves’ ability to send and receive information to and from the brain is compromised.

Symptoms of peripheral neuropathy vary based on the nerves involved and the degree of damage. Symptoms typically appear in the extremities (arms and legs) and include:

  • Anxiety and panic
  • Burning
  • Dizziness
  • Headaches
  • Malaise
  • Memory loss
  • Numbness
  • Pain
  • Psychosis
  • Shooting pain
  • Tingling
  • Weakness

Frighteningly, symptoms in the majority of cases appear within a few days of beginning treatment with FLQs. These symptoms may persist for months after FLQ treatment has been discontinued and, in some instances, the damage is permanent.

Treatment of Peripheral Neuropathy

Sadly, effective treatment depends upon early diagnosis due to the fact that the peripheral nerves have a limited regenerative ability. This means that in some cases, treatment only slows the condition’s progression. Patients who have been severely injured by FLQs could even require physical therapy to regain lost strength and prevent muscle spasms and/or cramping.

Often, with early diagnosis, discontinued use of FLQs may be enough to reverse the damage or at least lessen its impact. You should always bring issues with medications to your health care provider’s attention before self-diagnosing or stopping medications.

FDA Involvement and Warning History

Ultimately, the FDA has required that all FLQ labels be updated to include warnings of possibility that the risks of damage caused by using the drugs are irreversible. Several FLQs have been pulled from the market. Those remaining now have Black Box Warnings stating the risk of serious injuries.

According to a Drug Safety Communication from the FDA in August 2013, patients using FLQs had experienced peripheral neuropathy. The agency issued the statement because it determined that earlier warnings didn’t adequately describe the possibility of rapid-onset peripheral neuropathy. The statement said, in part, “In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone. Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms.”

Then, in May 2016, the agency mandated new warnings for FLQ labels. These new warnings mentioned the increased risk of nerve and muscle damage.

On July 26, 2016, the FDA changed the warnings again. This time, the agency said FLQs were too strong a drug for treating sinusitis, bronchitis and simple UTIs. According to the FDA: “While these drugs are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system.”

The very next day, July 27, 2016, the FDA updated the boxed warnings for FLQs to include warnings of “disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system” connected with FLQ use. The FDA warned that the only patients who should be treated with FLQs are those with acute bacterial sinus infections, acute exacerbation of chronic bronchitis, and uncomplicated UTIs and who had no other treatment options available to them. The agency’s reasoning was that the risks associated with FLQ use typically outweighed the drugs’ benefits.

Studies

FLQ makers are facing large numbers of lawsuits claiming that they concealed the risks associated with using their products from health care providers and the public for decades. The suits claim that the drug makers knew or should have known of the risks, but chose to remain silent in the name of profits.

Specifically, the lawsuits against Johnson & Johnson and Janssen Pharmaceuticals (makers of Levaquin) and Bayer Healthcare and Merck & Co. (makers of Avelox), claim that:

  • Studies linking FLQs to peripheral neuropathy were available as early as 1992
  • The drug makers knew about or should have been aware of these studies
  • The companies ignored the studies and continued to market FLQs as effective and safe
  • The companies hid the knowledge of the risk of rapid-onset peripheral neuropathy and its potential to be permanent
  • No “Dear Doctor” letters explaining the 2013 label updates were sent, thus leaving health care providers and patient unaware of the serious risks mentioned in the new warning

In November 2015, JAMA Internal Medicine published a study linking FLQ use to aortic dissection and aortic aneurysm. The scientists found that FLQs had been linked to collagen degradation, which could lead to severe collagen disorders. Among such disorders were aortic dissection and aortic aneurysm. The study compared 1,477 patients who had been hospitalized for aortic dissection or aortic aneurysm to 147,700 control patients.

According to the study, “After propensity score adjustment, current use of fluoroquinolones was found to be associated with increased risk for aortic aneurysm or dissection (rate ratio [RR], 2.43; 95% CI, 1.83-3.22), as was past use, although this risk was attenuated (RR, 1.48; 95% CI, 1.18-1.86). Sensitivity analysis focusing on aortic aneurysm and dissection requiring surgery also demonstrated an increased risk associated with current fluoroquinolone use, but the increase was not statistically significant (propensity score–adjusted RR, 2.15; 95% CI, 0.97-4.60).While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”

Enter the Quinolone Vigilance Foundation

The QVF works to increase the public’s awareness of the dangers of FLQ use. It also funds research on FLQ damage and advocates for still stronger warnings. Another of the QVF’s missions is to have FLQ use limited to those with life-threatening infections. More information about FLQs and the associated risks can be found at the Quinolone Vigilance Foundation.

FLQ Lawsuits

There are many state and federal FLQ lawsuits involving peripheral neuropathy, other severe nerve damage or aortic dissection still pending. Many of these were consolidated in a multi-district litigation (MDL) in Minnesota, U.S. District Judge John R. Tunheim presiding. At one time, the MDL had over 2,000 Levaquin cases, many of which were settled. The terms of the settlements between the plaintiffs and Johnson & Johnson were confidential. Roughly 100 cases remained in the MDL as of March 2015.

Avelox cases have been filed, but those are still only in state courts.

The Time to Act is now!

Dangerous drug lawsuits are complex pieces of litigation. You need an experienced team of attorneys on your side, fighting for your rights. The team at Justinian and Associates is experienced in such suits, as well as handling MDLs. The Statute of Limitations (the amount of time you have to file your claim) may already be running out, meaning you could lose your chance for justice. Don’t delay! Call us for a free consultation and let us fight for you.

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