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Fluoroquinolone lawsuits backed by science

Numerous patients who allege that a fluoroquinolone antibiotic is linked to their peripheral neuropathy diagnosis are filing lawsuits nationwide against the makers of these drugs. A panel of federal judges meeting today in San Francisco will decide whether to transfer a lot of these federal fluoroquinolone lawsuits to one court, U.S. District Court for the Southern District of Illinois, for pretrial proceedings.

In the meantime, anyone who has used one or more of the following fluoroquinolone drugs and who since has been diagnosed with peripheral neuropathy may want to contact an attorney to discuss potential legal action:

  • Avelox
  • Cipro
  • Factive
  • Floxin
  • Levaquin
  • Noroxin

The litigation is not solely about a peripheral neuropathy diagnosis. It is also about the fact that the condition, in many patients, has been irreversible.

The U.S. Food and Drug Administration weighed in to protect patients in August 2013, when it explained in a safety advisory that it "has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent."

The federal agency further explained, "If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk ... It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent. Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should tell their health care professionals right away."

An Indianapolis-based researcher examined reports of adverse events that patients and members of the health care industry sent to the FDA between 1997 and 2012. Writing about the findings for the April 2014 edition of the journal Annals in Epidemiology, the author explained that the study's fundamental premise was that "peripheral neuropathy (PN) is an identified risk of systemic antibacterial therapy with fluoroquinolones" and that "the risk and its severity, including the development of Guillain-Barré syndrome (GBS) between individual agents is uncertain."

The research showed that "GBS and PN, respectively, ranked sixth and eighth among reported neurologic events." Thus, researchers concluded, "This study re-emphasizes the link between fluoroquinolones and PN and shows the potential association with more severe forms of nerve damage, for example, GBS. Unless the benefit of fluoroquinolone therapy (e.g., overwhelming infection or development of bacterial resistance) outweighs PN risk, treatment with alternative antibacterial agents is recommended."

The FDA describes peripheral neuropathy as a "nerve disorder occurring in the arms or legs," the symptoms of which include, "pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position."

An article that the medical journal PLOS One released July 22 described Guillain-Barré syndrome as a "neurological disorder that is characterized by symmetrical weakness of the limbs, which reaches a maximum severity within four weeks."

Fluoroquinolone manufacturers named in the litigation have generally opposed centralizing the cases before one judge. In their brief submitted June 17 to the U.S. Judicial Panel on Multidistrict Litigation, several plaintiffs responded to defendants' motion against grouping the cases together.

"Defendants claim that consolidation is inappropriate because these cases involve 'highly individualized issues' specific to each plaintiff's claims," the plaintiffs' joint brief reads. "However, it is undeniable that all actions share allegations and common factual issues concerning the safety of FLQs and their tendency to cause or increase the risk of developing irreversible peripheral neuropathy. In fact, there is a large body of scientific and medical literature concerning the FLQ class of antibiotics as a whole. Moreover, the issue of whether Avelox, Cipro and/or Levaquin can cause irreversible peripheral nerve damage was deemed a class issue by the Food and Drug Administration."

Plaintiffs further asserted in their brief, "Indeed, the FDA required manufacturers of all FLQs that are taken by mouth or by injection to revise the existing warnings regarding irreversible peripheral nerve damage. In short, when addressing FLQs, and specifically the risk associated with FLQ use and irreversible peripheral neuropathy, regulators, scientists and doctors alike recognize the commonality among Avelox, Levaquin and Cipro and so should this Panel."

Hence, many fluoroquinolone alleged victims, who since using one of the drugs have suffered from lingering peripheral neuropathy, have contacted an attorney.

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