Avelox (moxifloxacin) is a fluoroquinolone antibiotic which like other quinolones or “floxins” was previously used to treat a wide range of infections in adults. Its use is now restricted to serious infections which cannot be treated with other antibiotics and is only to be used in adults unless no other options exist.
Avelox’s manufacturer, Bayer, is facing multiple lawsuits for serious injuries which have been caused by the antibiotic such as:
- Tendon rupture
- Neurological damage
- Aortic aneurysm
- Aortic dissection
These side effects may be serious, permanent or life-threatening.
Though it was once approved to treat a wide variety of infections, it is now restricted and may be used to treat:
- Community-acquired or nosocomial pneumonia
- Uncomplicated skin and structure infections caused by MRSA
- Complicated skin and structure infections
- Complicated Intra-abdominal infections
- Plague
Avelox use in the following infections should be limited to patients who have no other treatment options:
- Acute bacterial sinusitis
- Acute bacterial exacerbation of chronic bronchitis
Avelox Aortic Aneurysm or Aortic Dissection
Avelox may disrupt collagen formation and destabilize collagen structure which can have negative consequences for cartilage and other tissues made of collagen. This is the way in which Avelox may cause tendon rupture and may contribute to breakdown of the rigid structure of the aorta, the largest blood vessel in the body.
Avelox and other fluoroquinolone’s effects on collagen in the aorta may allow the wall of the blood vessel to bulge as an aortic aneurysm or separate and tear as an aortic dissection. A ruptured or torn aorta due to aneurysm or dissection will quickly result in massive blood loss death due to hemorrhage.
In December 2018, the U.S. Food and Drug Administration (FDA) issued a warning regarding Avelox and other fluoroquinolones, stating that the medication increase the risk of aortic injuries which may be fatal. The risk begins shortly after the medication is started and lasts for up to 60 days after medications are discontinued.
Avelox use should be restricted to approved conditions and should be limited in patients who are at greater risk of collagen-related injuries including those who are elderly, have high blood pressure or who have a history of collagen disorder.
Avelox Side Effects
Fluoroquinolones or “floxins” like Avelox work by limiting bacterial cell division and repair through inhibition of enzymes needed for DNA production. Like all medications, Avelox causes side effects. While most side effects are tolerable and will go away with time, some Avelos side effects may be more serious or even life-threatening.
Common Avelox side effects can include:
- Nausea and vomiting
- Diarrhea or constipation
- Headache
- Dizziness
- Itching
- Vaginitis
More serious Avelox effects can include:
- Nerve damage in extremities (arms, legs)
- Central nervous system effects
- Severe allergy effects including anaphylaxis
- Tendinopathy or tendon rupture
- Aortic aneurysm or aortic dissection
Symptoms of these serious Avelox side effects should be reported to a medical professional. Certain symptoms such as chest pain, abdominal pain, sudden pain in arms or legs, difficulty breathing or change in consciousness should be considered a medical emergency.
Avelox FDA Warnings
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 2002. A black box warning is the most severe type of warning that is issued by the FDA.
Since its issuance in 2002, the Avelox black box statement has been updated several times, with the most recent safety alerts being issued in December 2018.
Avelox’s black box statements warn of a risk of:
- Peripheral nerve damage
- Central nervous system damage
- Tendon rupture
- Exacerbation of myasthenia gravis
The boxed statement warning also 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 should be limited in patients who are at greater risk for cartilage disruption, such as the elderly.
Avelox Lawsuits
Bayer, Avelox’s manufacturer, may be facing lawsuits for injuries caused by Avelox and another fluoroquinolone, Cipro.
People have filed Avelox lawsuits for:
- Neurological damage
- Tendon rupture
- Aortic aneurysm
- Aortic dissection
- Death
Avelox lawsuits filed in federal courts, have been consolidated, along with Cipro lawsuits into multidistrict litigation (MDL) in the U.S. District Court for the District of Minnesota. There may be additional Avelox lawsuits pending in state courts in a number of states including California, Pennsylvania, Oklahoma, New Jersey and others.
Other manufacturers have faced fluoroquinolone lawsuits as well, including Johnson & Johnson, who reportedly settled between 845 and 3,000 Levaquin lawsuits against its subsidiary, Janssen. J & J has since then, decided to discontinue manufacturing Levaquin but Bayer has not followed suit and is still selling Cipro and Avelox.
Avelox lawsuits have not yet gone to trial and no lawsuit settlements have been announced but people who have been injured by the medication may be eligible for compensation for medical costs, lost wages, pain and suffering and other costs. Anyone who took Avelox or another fluoroquinolone like Cipro and experienced severe side effects or serious injury should have their case evaluated by experienced lawyers.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
