Lawsuit Information Center
Avelox can cause peripheral neuropathy within days of use. This condition is a type of nerve damage. It is extremely serious. It can cause muscle weakness, numbness, and pain that can potentially last a lifetime. We are rapidly learning more about the connection between Avelox and neuropathy.
Avelox
Avelox, known by its generic name moxifloxacin, is part of the fluoroquinolone class of antibiotics. This broad-spectrum antibiotic is designed to combat a wide array of bacterial infections by disrupting the bacteria’s ability to replicate DNA, which is essential for their survival and propagation. Owing to its effectiveness against both gram-positive and gram-negative bacteria, as well as atypical bacterial strains, it is predominantly prescribed for treating respiratory tract infections, skin infections, and certain abdominal infections.
There is no question, the drug has worked for many people. Moxifloxacin is particularly valued for its efficacy against acute bacterial exacerbations of chronic bronchitis, community-acquired pneumonia, and complicated skin and skin structure infections. It is also occasionally used to treat acute bacterial sinusitis, although its use is tempered by the potential for serious side effects. No one is arguing that Avelox is not a valuable tool in the medical arsenal against infections, even for children, especially where other antibiotics might fail to provide effective treatment. They fear is the risks that some with it.
Avelox History
Avelox is a fourth-generation synthetic fluoroquinolone antibiotic. It is sold in over 80 countries worldwide and is available in intravenous, topical, and oral forms. It is effective at treating gram-negative and gram-positive bacteria such as Escherichia coli (E. choli) and Streptococcus Pneumoniae. Avelox works by interfering with bacterial DNA gyrase. During this process, the drug binds to certain enzymes, preventing DNA replication.
Unfortunately, despite these positive benefits, the drug also interacts with a variety of different receptors in the central nervous system (including GABAa receptors). GABAa receptors are found throughout the central nervous system. When activated, GABAa receptors cause hyperpolarization of the neurons, inhibiting neurotransmission of critical information. The net effect is that a patient begins experiencing peripheral neuropathy, a condition characterized by pain, burning, tingling, numbness, weakness, sensitivity, and lack of neuromuscular coordination. This condition often appears very quickly after taking Avelox and may last for an indefinite period of time. In many cases, the condition may be permanent.
Avelox was first approved by the United States Food and Drugs Administration in 1999. Recent lawsuits have alleged that as early as 2001, Avelox’s manufacturer, Bayer and Merck, were aware of the risks associated with Avelox and peripheral neuropathy and yet did nothing about it. In fact, in one of the first post marketing studies in 2001, researchers found a clear association between the drug and long-term nerve damage. Despite knowing these risk factors, Bayer and Merck continued to market the drug with little or no warnings in either the package insert or on the box itself.
Side Effects of Avelox
The use of Avelox, while beneficial for treating severe infections, is associated with a range of side effects. Commonly, patients may experience gastrointestinal issues such as nausea, diarrhea, and vomiting. The antibiotic can also impact the central nervous system, leading to symptoms like dizziness, headaches, and confusion. More serious are the cardiac concerns; moxifloxacin can alter heart rhythms, a condition known as QT prolongation, which can be potentially life-threatening.
What We Have Now Learned About Avelox and Neuropathy
Among the most severe side effects linked to Avelox and other fluoroquinolones is peripheral neuropathy. This condition entails damage to the peripheral nerves, which facilitate communication between the brain, the spinal cord, and the rest of the body. Symptoms of neuropathy can manifest as sharp or burning pain, often in the limbs, alongside sensations of numbness or tingling, commonly referred to as “pins and needles.”
Affected individuals may also experience muscle weakness, impacting their daily functionality, and changes in sensitivity to temperature, touch, or pain. The onset of these symptoms can be rapid and may occur shortly after the commencement of treatment, with the potential to become permanent in some cases. The suspected underlying mechanism involves oxidative stress and mitochondrial damage within nerve cells, leading to dysfunction and death of these cells.
In August 2013, the FDA required new warnings regarding the effects of Avelox and neuropathy. These warnings were supposed to be included in the package insert and on the product’s packaging material. The FDA safety announcement specified that “the U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.” Included in this announcement was data dating back to 2003 indicating a continued association between fluoroquinolone use and disabling peripheral neuropathy.
Unfortunately, for many individuals these changes come too late in the game. Many doctors have been prescribing Avelox for years, and for many patients, the effects of Avelox have become long-lasting and permanent.
Fortunately, some patients have decided to fight back, filing lawsuits against the manufacturers of Avelox in federal court alleging failure to warn, negligence, breach of express warranty, breach of implied warranty, fraud, negligent misrepresentation, fraudulent concealment, strict liability, violation of consumer protection laws, and negligent infliction of emotional distress. Many of these lawsuits are seeking both compensatory and punitive damages.
Avelox Lawsuits
Many lawsuits have claimed that Avelox, along with other fluoroquinolones like Cipro and Levaquin, can cause permanent nerve damage. Plaintiffs in these cases allege that Bayer and other manufacturers failed to provide adequate warnings about the risk of developing peripheral neuropathy, despite evidence linking the drug to this severe side effect. Our law firm did not handle these lawsuits and our understanding is that they were not very successful for plaintiffs.
New Avelox lawsuits alleging peripheral neuropathy are even more difficult for claims after 2016 when the FDA further enhanced warning labels to describe the serious side effects of fluoroquinolones, advising that they should only be used as a last resort in cases where no alternative treatment options exist.
Most Recent Avelox Lawsuit We Have Seen
The last Avelox lawsuit we have seen – not that there have not been others, we do not know – was filed in 2022 in federal court in Connecticut. The plaintiffs sued Baye, Johnson & Johnson, and Jansen. The claim revolved around the prescription fluoroquinolone antibiotics Avelox, Cipro (ciprofloxacin), and Levaquin (levofloxacin).
The plaintiffs allege that these drugs, which were designed, manufactured, and sold by the Bayer (Cipro and Avelox) and the J&J/Jansen are defective, dangerous, and unsuitable for the market. They claim the drugs were marketed for infections that did not require such severe treatments and lacked proper warnings about severe risks including irreversible neurogenic pain, collagen toxicity, tendinopathy, and aortic disease. These severe side effects have led to substantial health issues fort the plaintiff including an aortic aneurysm requiring surgical intervention and permanent heart function damage, alongside other physical and mental sufferings. (The case number is 22-cv-672 if you have an interest in pulling it up.)
Our take is that new moxifloxacin lawsuits are very difficult claims to bring.