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FDA Evaluating Fluoroquinolone Antibiotics for Peripheral Sensorimotor Neuropathy

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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.

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Fluoroquinolone Drugs

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

Fluoroquinolones and Peripheral Neuropathy

levaquintendonruptureslevquinlawsuitPeripheral 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.

Fluoroquinolones and Tendon Rupture

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.

levaquinantibioticsideeffectsIn 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.

Fluroquinolone Legal Help

If you or a loved one has suffered damages for a Fluorquinolone drug, please click the link below and your complaint will be sent to a lawyer specializing in these cases who may evaluate your claim at no cost or obligation.
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FLUORQUINOLONE LEGAL ARTICLES AND INTERVIEWS

Woman Files Lawsuit Against the Makers of the Fluoroquinolone Avelox
Woman Files Lawsuit Against the Makers of the Fluoroquinolone Avelox
March 3, 2015
Los Angeles, CA Bayer and Merck are facing a product liability lawsuit filed by a woman from Nebraska who alleges she developed peripheral neuropathy while on the popular antibiotic Avelox.[READ MORE]

What Fluoroquinolone Peripheral Sensorimotor Neuropathy Looks Like
What Fluoroquinolone Peripheral Sensorimotor Neuropathy Looks Like
December 18, 2014
Washington, DC It’s little wonder the US Food and Drug Administration (FDA) is in the throes of taking a good hard look at fluoroquinolones (FQs) and their association with Peripheral Sensorimotor Neuropathy. An important Canadian study appearing in late September in the Journal Neurology has the medical community talking. With headlines screaming “FDA Evaluating Fluoroquinolone Antibiotics,” it’s no surprise that everyday consumers are talking too, given that antibiotics such as Levaquin and Cipro are oft-prescribed for a wide variety of serious infections [READ MORE]

Study Links Popular Oral Antibiotics to Increased Risk of Nerve Damage
Study Links Popular Oral Antibiotics to Increased Risk of Nerve Damage
August 23, 2014
Vancouver, BC A Canadian-US research team has made an important and scientifically proven link between a class of potent and commonly used antibiotics known as fluoroquinolones (FQs) and a condition known as peripheral neuropathy (PN) [READ MORE]



READER COMMENTS

Posted by
Washington
on
Only had Cipro once back in 1997 at the University of WA via IV for UTI. I was getting a sural nerve biopsy to determine vasculitis/Sjogren's Syndrome. I began going into anaphylaxis and had to be treated STAT. Not long after that I began to have “patches” of numbness in my face, arms and legs. My neurologist cannot find an explanation and has diagnosed me with mononeuritis multiplex. My left arm and hand are worse than the right and the PN is horrible. I take Gabapentin to help with the unending itching, burning and feelings of “pressure” in my arms, neck, and legs. I have lived with this for 17 years.

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