Levaquin (levofloxacin) is a fluoroquinolone antibiotic used to treat bacterial infections in many areas of the body. Due to serious side effects being caused by the medication, Levaquin’s use had been restricted to complicated infections and used only when other treatments were not possible.
In 2018, Levaquin’s manufacturer Ortho-McNeil-Janssen, a division of healthcare giant Johnson & Johnson announced that they would no longer make the medication. This move by J & J came after reports of serious side effects, some of which were life-threatening, had increased in number. Johnson & Johnson and its subsidiaries has faced thousands of lawsuits for injuries caused by Levaquin. Reportedly, 845 Levaquin lawsuits were settled but the number may have been much higher, possibly up to 3,000.
The manufacturer may still be facing hundreds or even thousands of lawsuits for serious injuries including:
- Tendon rupture
- Neurological damage
- Aortic dissection
- Aortic aneurysm
Levaquin is a fluoroquinolone or “floxin” antibiotic which works by inhibiting DNA synthesis to block bacterial reproduction and repair. It is related to other fluoroquinolones including Cipro (ciprofloxacin) and Avelox (moxifloxacin).
Though it was originally used for a wide range of infections, serious side effects limited use to more severe infections which could not be treated with other medications including:
- Acute pyelonephritis
- Complicated urinary infection
- Complicated skin and structure infections
- Nosocomial or community-acquired pneumonia
- Chronic prostate infection
- Anthrax exposure
and in the following infections when no alternative treatments exist:
- Acute bacterial sinusitis
- Uncomplicated urinary tract infection
- Acute bacterial exacerbation of chronic bronchitis
Levaquin Side Effects
Like all medications, Levaquin carries a number of side effect warnings. Some of these side effects may pose a serious or even life-threatening risk. .
Common Levaquin side effects include:
- Nausea and vomiting
- Diarrhea or constipation
More serious Levaquin side effects include:
- Tendon rupture or damage
- Anaphylaxis or severe allergic reaction
- Central nervous system effects
- Peripheral neuropathy or nerve damage
- Aortic aneurysm or dissection
Symptoms of serious Levaquin complications may include:
- Chest pain
- Abdominal pain
- Sudden pain in arms or legs
- Changes in consciousness
- Difficulty breathing
These symptoms should be treated as a medical emergency as they may indicate a life-threatening event.
Levaquin FDA Warnings
The U.S. Food and Drug Administration (FDA) required that prescribing information for Levaquin and other fluoroquinolones include “black box” or “boxed statement” warnings agout the possibility of central nervous system (CNS) effects, tendon rupture and allergic reactions.
The warnings also recommend that Levaquin use be limited to certain complicated infections and for simple infections, avoided unless no alternative medications exist. Levaquin may also exacerbate the symptoms of the nerve disorder, myasthenia gravis and should not be used in patients with a history of this disease.
Levaquin Aortic Aneurysm and Aortic Dissection
Levaquin may have negative action on collagen, which forms the primary structure for tendons and other tissues in the body including the rigid structure of the largest blood vessel in the body, the aorta. When drugs like Levaquin cause collagen to break down, the aorta may become weakened allowing the vessel to bulge or layers to separate. When this occurs, the vessel may rupture which allows for hemorrhage or massive bleeding and is generally fatal within a short period of time.
Certain patient populations should not use Levaquin including those who are at greater risk for collagen breakdown or disorders due to risk of aortic injuries or tendon rupture. These groups may include the elderly, people with high blood pressure, those with collagen disorders or children.
In 2010, Johnson & Johnson and subsidiaries Ortho McNeil-Janssen, lost the first lawsuit filed due to a Levaquin injury. The plaintiff was awarded $1.8 million and in 2012, J & J quietly settled 845 lawsuits for undisclosed amounts. It was reported at the time that they may have faced more than 3,000 Levaquin lawsuits but no additional settlements were announced.
A RICO lawsuit was filed against J & J in 2016, claiming that the manufacturer hid safety information intentionally to defraud the public and a new wave of medical injury lawsuits was expected against the company. Though no announcements have been made regarding disposition of these lawsuits or settlement offers, the company has opted to discontinue manufacturing Levaquin.
J & J did not recall Levaquin doses that had already been produced and shipped to pharmacies but has stated that all existing doses will expire by 2020 and is no longer making new doses. A multidistrict litigation lawsuit has gathered for other fluoroquinolones and legal experts are still waiting to see how that will affect pending Levaquin litigation.
People who have been injured or loved ones of those who may have died after using Levaquin should seek advice from an attorney.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.