LEVAQUIN – LEVOFLOXACIN

Peripheral Neuropathy: Potentially permanent nerve damage causing debilitating pain

DESCRIPTION

LEVAQUIN (levofloxacin) is a powerful antibiotic available in tablet and intravenous forms that is designed to treat a number of serious infections. Levaquin is one of the many powerful antibacterial flouroquinolone drugs, including Cipro (ciprofloxacin) and others (see list below). The drug has been linked to an increased risk of peripheral neuropathy, nerve damage causing pain and sharp “tingling” mostly in legs, arms, feet and legs.

Levaquin was the best-selling antibiotic in 2010; it is manufacturered and marketed by Ortho-McNeil-Janssen Pharmaceutical.

LAWSUITS BEING FILED

Sheller, P.C. defective drugs attorneys are advising individuals nationwide who have experienced peripheral neuropathy on their legal rights and whether they have cause for a lawsuit. Fill out the inquiry form at the bottom of this page or call 800-883-229 for a no obligation, no cost initial consultation.

KFOR Newschannel 4 video (video may be preceeded by ad):

Earlier litigation, December 8, 2010: First Levaquin Injury Lawsuit related to tendon rupture garners $1.8 million jury verdict, $700,000 damages and $1.1 million punitive.

WHAT ARE THE SYMPTOMS INDICATING YOU MAY BE AT RISK?

Signs and symptoms of peripheral neuropathy may include:

  • Muscle weakness
  • Paralysis if motor nerves are affected
  • Sharp jabbing pain
  • Extreme senstivity to touch
  • Lack of coordination or touching
  • Gradual onset of numbness and tingling in your hands and feet which may spread upward to your legs and arms

WHAT ARE THE FDA WARNINGS?

In 2013, the FDA required LEVAQUIN manufacturers to include new warnings about the risk of peripheral neuropathy and nerve damage.

In July 2008 the FDA ordered Ortho-McNeil and other pharmaceutical companies to add “Black Box” warnings for LEVAQUIN and other fluoroquinolones. The increased warnings identified an even greater risk of tendon ruptures and serious tendonitis. At that time, the FDA issued a Patient Safety News Alert video, click here. The FDA required Ortho-McNeil to send physicians and other health care professionals a  “Dear Doctor” letter to stress the importance of the warnings. In April 2009, due to the FDA’s ongoing and increased concern over LEVAQUIN’s safety based on growing reports of injuries, the agency required Ortho-McNeil to submit a “Risk Evaluation and Mitigation Strategy,” which requires the manufacturer to continue reporting post-marketing research and risks of an approved drug. In 2013, the FDA required the manufacturer to add peripheral neuropathy to the warning label.

Even though LEVAQUIN was approved by the FDA more than 15 years ago, numerous postmarket evaluation and medical injury reports from consumers and physicians indicate a number of dangerous and potentially fatal side effects. Fluoroquinolone antibiotics were developed and put on the fast track for FDA approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects and toxicity within the general population. After gaining FDA approval, the new fluoroquinolones were aggressively marketed by the manufacturers. In doing so, the manufacturers failed to provide adequate warnings to the prescribing physicians of the dangers, risks and adverse side effects associated with fluoroquinolones.

Combining LEVAQUIN with other prescription or over the counter (OTC) drugs can be dangerous.

Compounding the problem is that there are numerous drugs which should not be taken in combination with fluoroquinolones. There are increased risks of injury when fluoroquinolones are taken in combination with corticosteriods (e.g.: Prednisone, Flovent, Nasarel, Azmacort, Advair Diskus, Methylprednisolone Dospak, Elocon Cream, Desoximetasone Cream, and Sterapred) and when taken in combinations with non-steroidal anti-inflamatory drugs (NSAIDs) (e.g.: Motrin, Pamprin, Aleve, Advil, and ibuprofen). Physicians may also not be able to identify that their patient is suffering an adverse reaction and instruct them to continue to take more fluoroquinolones resulting in very serious and perhaps preventable injuries. FDA letter from 4/27/

Other fluoroquinolone antibiotic drugs include:

  • Avelox (moxifloxacin)
    Cipro (ciprofloxacin)
    ProquinXR (ciprofloxacin extended release)
    Factive (gemifloxacin)
    Noroxin (norfloxacin)
    Floxin (ofloxacin)
    Proquin (ciprofloxacin hydrochloride)
    Tequin (gatifloxacin)

Earlier Levaquin litigation, December 8, 2010: First Levaquin Injury Lawsuit related to tendon rupture garners $1.8 million jury verdict,$700,000 damages and $1.1 million punitive.

If you have a diagnosis of periopheral neuropathy and have been taking LEVAQUIN for more than one year, contact us now by calling 800-883-2299, filling out the form on this page for a no obligation consultation about your legal rights.

LINKS & RESOURCES

FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damange from antibacterial fluroroquinolone drugs taken by mouth or injection, August 15, 2013

FDA Patient Safety Video mpg file