Paul Tassin  |  May 6, 2015

Category: Legal News

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quinolone-nerve-painA popular class of antibiotics can  damage the peripheral nerves, causing injuries that are painful and sometimes permanent.

Fluoroquinolones, or simply quinolones, are a class of antibiotics that include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). Use of quinolones is fairly common. Over 23 million patients were prescribed quinolone antibiotics in 2011.

They have been linked to a number of harmful side effects including tendon ruptures, retinal detachment, and kidney problems. Recent litigation has raised the issue of a link between quinolone antibiotics and development of peripheral neuropathy.

Peripheral neuropathy is the technical term for damage to the nerves outside the central nervous system. Characteristic symptoms are sensory aberrations such as pain, numbness, tingling, or a burning sensation. It can also cause changes in the sense of body position or in the sensory response to pain, heat, or light touch.

Diagnosis is usually by self-reported symptoms, though an electromyography or nerve conduction study can confirm whether there is actual damage to the nerve. Treating quinolone peripheral neuropathy requires the patient first to stop taking the antibiotic.

Once the medication is stopped, treatment focuses on relieving pain and muscle weakness. Quinolone peripheral neuropathy can continue for months or even years after cessation of quinolone therapy. In some cases, it is permanent.

FDA Mandates a Clearer Warning

In August 2013, the FDA issued a Drug Safety Communication mandating a change in the labeling and Medication Guides for quinolone antibiotics to better reflect their associated risk of peripheral neuropathy. The original warning label requirement was first imposed in 2004, but the FDA now says that warning did not accurately describe the potentially rapid onset and risk of permanence of quinolone neuropathy.

The agency based this new requirement on adverse event reports of quinolone peripheral neuropathy received between January 2003 and August 2012. They found many reports of rapid-onset peripheral neuropathy, frequently within days of starting quinolone therapy.

The FDA recommends that physicians prescribing quinolones warn their patients about the increased risk of peripheral neuropathy and that patients taking quinolones notify their physician immediately if they begin to experience peripheral neuropathy symptoms.

The FDA warning applies only to quinolones taken by mouth or by injection. It states there is no known risk of neuropathy associated with topical quinolones.

Quinolone Lawsuits

Since this new warning was issued, victims of quinolone peripheral neuropathy have begun seeking compensation from the drug’s manufacturers. A Maryland woman filed the first Levaquin lawsuit against Johnson & Johnson in September 2014. Bayer and Merck have been on the receiving end of Avelox lawsuits.

These quinolone lawsuits generally allege the manufacturers failed to properly warn consumers or their physicians about the risk of quinolone peripheral neuropathy. Some allege the manufacturers were on notice about that side effect as early as 2002, when the FDA started receiving adverse event reports of neuropathy associated with quinolones, yet the manufacturers failed to update their labeling information or their marketing to reflect that information.

Plaintiffs allege that had they known about the increased risk of neuropathy, they would not have taken a quinolone antibiotic.

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