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Two years since irreversible nerve damage on Levaquin label

September 2015 marked the second anniversary of the U.S. Food and Drug Administration's stricter warning in regard to the heighted risk of nerve damage associated with the use of the fluoroquinolone antibiotic Levaquin (levofloxacin). What we've known since that label update should have been made known a lot sooner, according to plaintiffs in Levaquin lawsuits, who allege the drug's warnings were inadequate at the time that they used the drug and subsequently were diagnosed with peripheral neuropathy.

The link between PN and Levaquin wasn't new two years ago. What was new was the fact that the onset of the disease can come on very soon after starting the drug and can last long after the patient ceased taking the drug. Hence, since September 2013, the Levaquin label contained key language to this effect: "Symptoms may occur soon after initiation of Levaquin and may be irreversible."

A peripheral neuropathy patient who filed a Levaquin lawsuit at federal court in San Francisco got right to the point in her December 2014 petition. Her petition reads, "The warning label for Levaquin during the period from September 2004 through August 2013 misled Plaintiff and her treating physician by incorrectly advising patients and physicians that peripheral neuropathy associated with Levaquin was 'rare' and in any case could be avoided by discontinuing the drug upon the onset of certain symptoms. The truth, however, is that the onset of irreversible peripheral neuropathy is often rapid and discontinuation of the drug will not ensure that the peripheral neuropathy is reversible."

The alleged victim also found fault with the way in which the manufacturer, Johnson & Johnson, downplayed the risk. As her brief reads, "Though this injury can be significant and debilitating, the language regarding the 'rare' risk of peripheral neuropathy was buried at the bottom of a long list of adverse reactions that were included on the Levaquin label; the language was in no way highlighted for the benefit of prescribing physicians and patients. Additionally, Defendants failed to disseminate a 'Dear Doctor' letter to physicians concerning the label change or the risk of irreversible peripheral neuropathy, and Defendants failed to disclose this serious and dangerous effect when promoting Levaquin to physicians."

The San Francisco Levaquin lawsuit accused the manufacturer and others of injury-causing negligence in many ways, among them:

  • "In failing to adequately warn Plaintiff and her health care providers that the use of Levaquin carried a risk of developing irreversible peripheral neuropathy."
  • "In failing to provide adequate post-marketing warnings or instructions after Defendant knew or should have known of the significant risk of irreversible peripheral neuropathy associated with the use of Levaquin."
  • "In failing to adequately and timely inform Plaintiff and the health care industry of the risk of serious personal injury, namely irreversible peripheral neuropathy, from Levaquin ingestion as described herein."

In April 2014, seven months after the FDA adjusted the Levaquin label to reflect the potential irreversibility of drug-induced peripheral neuropathy, the medical journal Annals of Epidemiology published an examination of the FDA's database of Levaquin-related adverse events.

The study, which looked at the risks of both peripheral neuropathy and of a peripheral nervous system disorder called Guillain-Barré syndrome, showed, "There were 539 PN reports out of 46,257 adverse event reports submitted for fluoroquinolones. Nine percent of PN reports were for GBS. Significant disproportionality of PN and GBS was identified for fluoroquinolones," including levofloxacin. The Indianapolis-based researchers discovered "signals of PN" in generic Levaquin users.

The author's bottom line was this: "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."

Anyone whose peripheral neuropathy diagnosis outlived the use of Levaquin or the use of another fluoroquinolone, should contact an attorney. The pharmaceutical injury attorneys at Reich & Binstock offer free consultations and are taking these cases from across the nation.

The following are also fluoroquinolones: Avelox, Cipro, Factive, Floxin, and Noroxin.

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