I recently heard that if we all keep taking antibiotics we will be responsible for creating the “superbug.” The theory is that since the advent of antibiotics nearly a century ago, we have caused bacteria to become so resilient that normal antibiotics will be ineffective in the not so far future. Incurable infection and bacteria will purportedly run rampant through the streets, and I can only assume that our society and landscape will be a barren wasteland similar to that of Mad Max. Ok, maybe not that last part, but there’s no denying that there has been a serious proliferation of antibiotics. While these have revolutionized medicine and generally increased health on the whole, there are complications that can arise unrelated to the infections that antibiotics are prescribed to treat.
Recently, a group of antibiotics referred to as “fluoroquinolones” has been linked to permanent nerve damage. The risk is real, and the side effect is referred to as peripheral neuropathy.
The Risks
Fluoroquinolones are the most widely used class of antibiotics. The class includes specific drugs such as Levaquin, Cipro, and Avelox, which are prescribed to an estimated 23 million people each year. Just like any bad drug, the antibiotics were marketed as safe and effective, however recent side effects are linking the drugs to a condition called “peripheral neuropathy.” This is a permanent form of damage that attacks the peripheral nervous system causing pain, weakness, burning, tingling, sensitivity to light, and motion in the arms or legs.
Here’s the thing, this is not exactly breaking news. Studies have shown a link between nerve damage and fluoroquinolones dating back to 1992. In 2001 an American study published the results of a long-term evaluation of patients with fluoroquinolone related nerve damage. Around 80% reported that they still felt the effects of the condition approximately a year after taking the medication. And half of that group reported the condition as “severe.”
Backlash and Response
In 2004, a nerve damage warning was added to the medication, but these warnings suggested that peripheral neuropathy was rare, not severe, and not permanent. False, false, and false.
2013, cue the federal government. The FDA picked up on these side effects as well and insisted that stronger warnings be added to certain fluoroquinolones given the risk of nerve damage. Specifically, the FDA’s warnings stressed that the problem might not be as rare as one may think. Plus, they mentioned that the risks actually exist long after the drug is out of your system. Luckily, doctors are now compelled to tell patients that are prescribed fluoroquinolones that, should they experience any symptoms of peripheral neuropathy, they should seek treatment and utilize a different antibiotic.
Problems like these arise when the drug company tries to sweep side effects under the rug. Here, this situation could have been avoided by the drug manufacturer warning people about the possible harmful effects of these antibiotics a long time ago. Luckily, patients are in a much better position to make a judgment call when it comes to whether they should take these drugs. The warnings are much clearer, but remember this is something that the drug manufacturers had knowledge about going back to 1992.
People are suing the manufacturers since they clearly failed to warn about the side effects of these drugs. Financial compensation is available to those who were affected by these unfortunate and permanent side effects.
Levaquin and Aortic Aneurysms and Dissections
According to a new study recently published in the Journal of the American College of Cardiology, exposure to drugs found in the family fluoroquinolone increased the risk of aortic aneurysms and dissections. Fluoroquinolone drugs include Levaquin and Cipro.
What are fluoroquinolones?
Fluoroquinolones are a family of antibacterial agents that are used primarily for respiratory and urinary tract infections. Drugs found in this family include Levaquin, Cipro, and Avelox.
What is Levaquin, and what is it used for?
Levofloxacin, most commonly known as Levaquin, is a fluoroquinolone used to treat bacterial infections in the lung, sinus, skin, or urinary tract.
What is Cipro?
Ciprofloxacin, most commonly known as Cipro, is a fluoroquinolone used to treat bone and joint conditions, endocarditis, gastrointestinal infections, intra-abdominal infections, and meningitis. It can also be used to treat anthrax exposure or plagues.
What is Avelox?
Moxifloxacin, most commonly known as Avelox, is a fluoroquinolone used to treat bacterial infections of the skin, sinuses, lungs, and stomach.
What are aortic aneurysms and dissections?
An aortic aneurysm is an irregular bulge that occurs in the aorta’s wall. The aorta is the major blood vessel that transports blood from the heart to the rest of the body. Aortic aneurysms can occur anywhere in the aorta. They can be either tube-shaped or round. There are two types of aortic aneurysms: abdominal and thoracic. An abdominal aortic aneurysm occurs in the part of the aorta that goes through the abdomen. A thoracic one occurs along the part of the aorta that goes through the chest cavity. Some individuals may have both abdominal and thoracic aortic aneurysms. Aortic aneurysms increase the risk of having an aortic dissection.
An aortic dissection occurs when the aorta’s inside walls tear. Blood surges through the tear which causes the aorta to separate, or dissect. An aortic dissection can be fatal if the blood surge ruptures outside the aortic wall. They are relatively uncommon and occur mostly in men in their 60s and 70s. Aortic dissection symptoms are similar to other diseases, which leads to late diagnoses. If an aortic dissection is detected and treated early enough, chances of survival significantly improve.
Details of the Taiwanese study
Taiwanese researchers studied the relationship between taking fluoroquinolone drugs and the risk of aortic aneurysms and dissections. They gathered data from Taiwan’s National Health Insurance Research Database (NHIRD). The data was used to conduct a nested case-control analysis of 1,477 case-patients and 147,700 control cases. A nested case-control study is a study that draws cases and controls from the same population. Case-patients consisted of individuals hospitalized for aortic aneurysms or dissections. Control patients were individuals who were not hospitalized for aortic aneurysms or dissections. Researchers matched 100 control patients to each individual case-patient based on age and sex.
Researchers looked at varying exposures to fluoroquinolone in patients who developed aortic aneurysms or dissections. They had three different categories that defined varying degrees of exposure. These categories are current, past, or any prior-year use. Current-use exposure meant having a filled fluoroquinolone prescription within the past 60 days of the aortic. Past-use meant having a filled prescription between 61 to 365 days. Prior-year use meant having a prescription filled for three or more days at any time during a one-year period prior to aortic aneurysm or dissection.
The study’s results showed increased exposure to fluoroquinolones increased the risk of aortic aneurysms and dissections. Both current and past use was associated with an increased risk for aortic aneurysms or dissections.
What has a previous study say about this issue?
Swedish researchers published a study that concluded that fluoroquinolone use increased the risk of an aortic aneurysm or dissection. They looked at connections between fluoroquinolone and aortic problems within the Swedish population. In addition, they compared amoxicillin use to fluoroquinolone use within a 60-day period. They gathered data from four different sources over a seven-year span. The first source was the National Prescribed Drug Register. This register records all prescriptions filled at all Swedish pharmacies. The second source was the National Patient Register. This register records hospital admissions, outpatient, and emergency department visits in Sweden. The third source was Statistics Sweden, which keeps track of demographics. The fourth source was the Swedish Cause of Death Register. This register keeps track of the causes of death in Sweden and death certificates. They concluded that fluoroquinolone use was associated with a 66% increased risk of an aortic aneurysm or dissection within a 60-day period. However, they noticed no increased risk of an aortic aneurysm or dissection after a 61 to 120-day period.
Other health risks associated with fluoroquinolones
There are other serious health risks that are associated with fluoroquinolones. One such health risk is lowered blood sugar. The FDA announced in July that they were strengthening label warnings that note fluoroquinolone side effects of lower blood sugar levels. Lower blood sugar levels can cause a coma, especially in diabetic patients.
Another health risk associated with fluoroquinolones is mental health issues. Fluoroquinolones may cause hallucinations, psychosis, confusion, depression, anxiety, and paranoia. Besides blood sugar, the FDA also included mental health in its July announcement.
Fluoroquinolones can also increase the risk of getting permanent nerve damage. In August 2013, the FDA announced they would be requiring label changes that emphasize the risk of peripheral neuropathy. It consists of conditions that damage the peripheral nervous system. Peripheral neuropathy occurs in the arms and legs. Symptoms include pain, burning, tingling, and numbness. Its effects can last for months or even years after one stops taking fluoroquinolones. It can sometimes be permanent as well.
Should I stop taking fluoroquinolones?
If you have experienced side effects such as the ones listed above, you should stop taking your medication. Always contact your doctor to let them know of any side effects you may have experienced upon taking fluoroquinolones.
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.