FDA Evaluating Fluoroquinolone Antibiotics for Peripheral Sensorimotor Neuropathy

Fluoroquinolone side effects reportedly include an increased risk of serious problems including peripheral neuropathy and tendon rupture. The reported link between fluoroquinolones and peripheral neuropathy has led the FDA to announce an updated warning label for the medications. In 2008, the FDA added a boxed warning to alert patients to the link between fluoroquinolones and tendon rupture.

Fluoroquinolone drugs are antibiotic medications used to treat or prevent certain bacterial infections. Included in the fluoroquinolone class are Avelox, Cipro and Levaquin.

Peripheral neuropathy is a nerve disorder of the arms or legs. Patients who develop it may experience pain, tingling, burning, numbness, weakness, or sensitivity to touch. According to the FDA peripheral neuropathy can develop any time during treatment with fluoroquinolones. Once it has developed, it can last years after treatment is stopped. In some patients, the symptoms are permanent.

The FDA recommends that patients who develop symptoms of peripheral neuropathy tell their health care professionals immediately and discuss their options.

The FDA announced the label change after a review of its Adverse Event Reporting System (AERS) showed a link between fluoroquinolones and disabling peripheral neuropathy. In its Drug Safety Communication, the FDA noted that AERS is a spontaneous reporting system it is not possible to calculate the incidence of peripheral neuropathy. This means that there could be more cases of peripheral neuropathy having developed than has been reported to the FDA.

In 2008, the FDA announced a boxed warning to the fluoroquinolone labels to include the increased risk of tendinitis and tendon rupture. At the time, the FDA noted that patients should discontinue fluoroquinolone use at the first sign of tendon pain, swelling or inflammation.

In 2012, Johnson & Johnson announced a settlement with approximately 850 patients who alleged they were not adequately warned about the risk of tendon damage from using Levaquin. At the time, the company reportedly faced more than 3,000 claims concerning the drug. According to a status conference update from July 16, 2014, there are currently 297 cases pending in the Levaquin multidistrict litigation, with approximately 100 of those being settled.

Lawsuits have been filed against fluoroquinolone makers concerning the risks of tendon rupture. Attorneys are investigating possible lawsuits concerning peripheral neuropathy.

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Last updated on Oct-24-14