Nerve Damage From Levaquin, Avelox May Be Caused By Mitochondrial Toxicity

As a growing number of Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits continue to be pursued by individuals throughout the United States who allege the manufacturers of these antibiotics failed to adequately warn about the risk of peripheral neuropathy, some experts are suggesting that the nerve problems may be linked to a much broader side effect known as mitochondrial toxicity. 

In 2013, the FDA issued a drug safety communication to announce that it is requiring the manufacturers of all antibiotics that are part of a class of medications known as fluoroquinolones to strengthen warning labels about the risk of peripheral neuropathy, which can cause users to suffer debilitating and potentially long-lasting nerve damage that may result in severe pain, burning, tingling, numbness, weakness and sensory impairments.

While prior warnings suggested that reports of antibiotic neuropathy problems were rare and often resolve once the medication is no longer used, the new update confirms that the issues may last for months or even years after an individual stops taking the antibiotic, potentially causing problems that lasts the rest of their life.

However, some health experts are suggesting that the FDA warnings do not go far enough, suggesting that the entire class of antibiotics should carry a black box warning about the risk of users developing a condition known as mitochondrial toxicity, which can not only result in long-term peripheral neuropathy, but may also increase the risk of muscle weakness, known as myopathy, as well as pancreatitis, Alzheimer’s disease, Lou Gehrig’s disease, liver damage, and Parkinson’s disease. Another severe side effect of mitochondrial toxicity involves lactic acidosis, which causes a build-up of lactic acid in the body that can cause organ failure and death.

Mitochondria are membranes found in cells that create the chemical energy those cells need to function. Mitochondrial toxicity, most often associated with antiretroviral drugs used to treat HIV, damages or reduces the amount of mitochondria in the body’s cells.

Mitochondrial Toxicity Warning Petition

Over the past summer, the Southern Network on Adverse Reactions (SONAR), based at the University of South Carolina, filed a citizen’s petition with the FDA to force the agency to add a mitochondrial toxicity black box warning to Levaquin, Avelox, Cipro and other related antibiotics.

According to the petition, research by the FDA and others have linked all fluoroquinolone antibiotics to a risk of mitochondrial damage. However, SONAR found that FDA’s adverse event database recorded a significantly higher number of complaints from doctors and patients involving problems with Levaquin than with other drugs of the same class.

SONAR notes in its petition that mitochondrial toxicity manifests in a number of ways, and has likely been reported to the FDA as other potential Levaquin side effects, such as liver damage.

The group estimates that mitochondrial toxicity could be the cause of as many as 31% of the nearly 80,000 Levaquin adverse events reported between November 1, 1997 and February 3, 2011. The group also notes that only between 1% and 10% of adverse events are estimated to actually be reported, suggesting the true extent of the problems may be substantially greater.

Stronger warnings about the risk of mitochondrial toxicity from Levaquin could lead doctors to consider using alternative antibiotics, according to the group. This could prevent consumers from suffering serious and potentially life-long complications, as well as reduce costs on the health care industry, Medicare and Medicaid.

A report published last month by researchers from the U.S. Centers for Disease Control and Prevention indicates that Levaquin is one of the most frequently prescribed antibiotics in hospitals in the U.S., and is often prescribed unnecessarily.

Levaquin and Similar Antibiotics Widely Used

Prior to introduction of generic equivalents in 2011, brand-name Levaquin generated more than $1.3 billion in sales each year and the drug was prescribed more than 430 million times worldwide.

According to the FDA, there are about 23.1 million patients who received a prescription for an oral fluoroquinolone in 2011. Cipro dominated the market, comprising 70% of those prescriptions, followed by Levaquin or a generic equivalent, which was used by 28%. Another 3.8 million patients received injections in 2011, with Levaquin or a generic equivalent making up 63% of those, followed by Cipro at 28%.

In July 2008, the FDA required that a “black box” warning be added about the tendon rupture risk with Levaquin and other fluoroquinolone antibiotics. However, the label update came at least two years after consumer advocates called for stronger tendon rupture warnings. The prominent consumer advocacy group Public Citizen filed a petition with the FDA in 2006, insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage.

Several thousand people throughout the United States who suffered a tendon rupture or other tendon damage after taking the drug subsequently pursued a Levaquin lawsuit against Johnson & Johnson, alleging that the drug maker withheld critical safety information about the drug by failing to update the warning label earlier.

As more and more individuals now discover that their may be a link between use of antibiotics like Levaquin and neuropathy problems they have been suffering for years, a new group of product liability lawsuits are now being pursued by individuals throughout the U.S., alleging that the drug makers withheld important safety information about the risk of nerve damage from consumers and the medical community.