Why Are There Avelox Lawsuits?
Bayer, manufacturer of the antibiotic Avelox, may be facing lawsuits for injuries caused by Avelox and another fluoroquinolone, Cipro. A study of 1.7 million patients (aged 65 and older) found that within 30 days of finishing a course of treatment, patients who received fluoroquinolones when 2.2 times more likely to experience aortic aneurysms.
Why Have Plaintiffs Filed Avelox Lawsuits?
People have filed Avelox lawsuits for:
- Neurological damage
- Tendon rupture
- Aortic aneurysm
- Aortic dissection
Because the companies may have failed to adequately warn doctors of the risks, doctors could not inform and instruct patients. The companies’ failure to warn may also have led to patients receiving these drugs instead of other adequate antibiotics, according to complaints filed in federal court.
Which Companies Are Facing Avelox Lawsuits?
Bayer, Johnson & Johnson, and Merck & Co. are among the manufacturers fighting lawsuits over aortic risks associated with their fluoroquinolone antibiotics. Companies being sued are those that developed, manufacture, and market the drugs.
The defendants deny that the drugs are defective or unreasonably dangerous. They also deny that their warnings were inadequate.
What Avelox Lawsuit Settlements Have There Been?
There are currently no publicized verdicts or settlements for aortic injury lawsuits associated with Avelox. However, these injuries are not the only reported side effects of fluoroquinolones that have prompted lawsuits. People who took Avelox and suffered from peripheral neuropathy and tendon ruptures have also sued the drug makers.
What Avelox Lawsuits Are There?
As of April 2019, there were 513 federal cases consolidated in pending multidistrict litigation (MDL) accusing fluoroquinolone drugs of causing peripheral neuropathy.
At the time, about 80 actions were pending in nearly 40 federal districts. Additional cases (some of which were transferred to the MDL) were also pending in state court in California, Pennsylvania, New Jersey, and Oklahoma.
More than 1,260 actions have been filed in the mass litigation. Several have been settled for confidential amounts, according to court documents. As of Oct. 14, 2022, only 13 cases were left pending in this MDL.
What Is Avelox?
Avelox (moxifloxacin) is a fluoroquinolone that inhibits certain bacteria that may cause infections like pneumonia and bronchitis. Avelox is most commonly taken in tablet or injection forms. This medication has been linked to serious and lethal adverse reactions. Because of this, the U.S. Food and Drug Administration (FDA) has advised that Avelox should be restricted to use in adults when no other antibiotic options exist.
What Is a Fluoroquinolone?
Fluoroquinolone is a class of antibiotics used to treat bacterial infections. There are many members of the fluoroquinolone class of antibiotics, with the most popular being Cipro, Levaquin, and Avelox.
Fluoroquinolones have been used to treat respiratory and urinary tract infections along with other infections. However, with the warnings from the FDA, their use has been limited to individuals who unable to take other antibiotics or when other medications have not worked.
How Does Avelox Work?
Fluoroquinolones or “floxins” like Avelox work by limiting bacterial cell division and repair through the inhibition of enzymes needed for DNA production. Essentially, it prevents the bacteria from growing and making the infection worse.
Avelox is used for bacterial infections and will not work on viral infections such as the common cold or flu. Using this antibiotic when it is not needed can cause resistance which means that it may not to work for future infections. Overuse of antibiotics may also increase the risk of experiencing adverse reactions.
Which Company Created Avelox?
Avelox, brand mname of generic moxifloxacin, was patented by Bayer A.G. in 1991 and again in 1997 for its use to treat bacterial infections. Avelox’s use has been restricted by the FDA’s warnings of adverse effects in patients after using Avelox.
When Was Avelox Approved by the FDA?
Avelox was first approved by the FDA for use to fight against bacterial infections on December 10, 1999. The updated FDA Boxed Warning for Avelox for the increased risks was added in July 2008.
What Is Avelox Prescribed To Treat?
Avelox was previously prescribed to treat all kinds of bacterial infections.
The FDA has since advised that it should be restricted to use for:
- Community-acquired pneumonia
- Uncomplicated skin and skin structure infections
- Complicated skin and skin structure infections
- Complicated intra-abdominal infections
- Pneumonic and septicemic plague
In addition, Avelox may be used for the following ailments, only when there are no other treatment options:
- Acute bacterial exacerbation of chronic bronchitis
- Acute bacterial sinusitis
What Are the Side Effects of Avelox?
Like all medications, Avelox may cause side effects. While most side effects are tolerable and will go away with time, some Avelox side effects may be more serious or even life-threatening.
What Are the Common Avelox Side Effects?
Common Avelox side effects may include:
- Nausea and vomiting
- Diarrhea or constipation
What Are the Serious Side Effects of Avelox?
More serious Avelox effects may include:
- Nerve damage in the extremities (arms, legs)
- Central nervous system effects (hallucinations, anxiety)
- Severe allergy effects including anaphylaxis
- Tendinopathy or tendon rupture
- Aortic aneurysm or aortic dissection
What Are the FDA’s Warnings About Avelox?
The U.S. Food and Drug Administration (FDA) began requiring that all fluoroquinolones, including Avelox, list “black box” or boxed statement warnings on all prescribing information in 2008. Since its issuance in 2008, the Avelox boxed warning has been updated several times, with the most recent safety alerts being issued in December 2018.
What Is a Boxed Warning?
A boxed warning -previously called a “black box” warning- is the highest safety-related warning the Food and Drug Administration assigns. These warnings may be added to, updated, and removed depending on what the FDA deems necessary. Boxed warnings are specifically used to warn medical professionals of the serious risks of a certain drug.
Why Does Avelox Have a Black Box Warning?
The boxed warning was first added to Avelox in July 2008 when there seemed to be an increased risk of tendinitis and tendon ruptures. In February 2011, the warning was updated to include the worsening symptoms in patients with myasthenia gravis as well as the warning for potentially permanent nerve damage in August of 2013. The serious update came in 2016 when it showed that Avelox (and other fluoroquinolones) were associated with disabling and potentially permanent side effects involving joints, tendons, muscles, and nerves.
Avelox’s boxed warning lists these risks:
- Peripheral nerve damage
- Central nervous system damage
- Tendon rupture
- Exacerbation of myasthenia gravis
Is Avelox Dangerous?
Avelox is an FDA-approved fluoroquinolone, but the boxed warnings indicate when to use and when not to use Avelox. The boxed statement warning recommends that Avelox use should be reserved for patients who have no other alternative treatment options for bacterial bronchitis or acute bacterial sinusitis. Avelox is not approved for use in children and use should be limited in patients who are at greater risk for cartilage disruption, such as the elderly.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.