Levaquin and Peripheral Neuropathy

Levaquin lawsuits claim that Levaquin medication has caused a number of tendon problems, including Levaquin tendon rupture, particularly Achilles tendon rupture. Levaquin has also reportedly been linked to an increased risk of peripheral neuropathy.

Levaquin (levofloxacin) is a member of a class of drugs known as quinolones. This powerful antibiotic, which was approved by the FDA in 1996, is manufactured by Ortho-McNeil Pharmaceuticals, a subsidiary of Johnson & Johnson, and is only available with a prescription. Levaquin was originally approved as a treatment for serious bacteria infections or infections that did not respond to other medicines. By 2002, however, Levaquin was among the most frequently prescribed drugs.

By 2010 over 700 cases of Levaquin tendon ruptures, including Achilles heal ruptures and rotator cuff damage, had been reported to the FDA (this number may account for only 10 percent of complaints).

The FDA has announced an updated warning label for drugs in the fluoroquinolone class to alert patients to the potential risk of peripheral neuropathy. Peripheral neuropathy is a nerve disorder of the arms or legs. It is marked by pain, burning, numbness, weakness, tingling or sensitivity to pain or touch. The FDA notes that peripheral neuropathy can develop at any time during treatment with fluoroquinolones and once it has developed symptoms may be permanent even if treatment is stopped.

The updated warning label came after a review of the Adverse Event Reporting System (AERS) suggested a link between fluoroquinolones and peripheral neuropathy.

Johnson & Johnson faces tens of thousands of Levaquin lawsuits filed by users who allege the drug caused tendon injuries, irreversible nerve damage and other serious Levaquin side effects.

Levaquin lawsuits claim that Ortho-McNeil Pharmaceutical did not provide adequate warnings to doctors and patients about the possibility of the drug causing such severe Levaquin side effects: the FDA has reported that more than 60 percent of fluoroquinolone-related tendon injuries are linked to Levaquin.

John Fratti of Hershey, PA, filed a Levaquin lawsuit against J&J in 2009, claiming that Levaquin caused debilitating side effects, including extreme pain in his arms and legs, tendon injuries and nerve damage.

In 2012, Johnson & Johnson announced a settlement with around 850 patients who alleged they were harmed by the use of Levaquin and suffered tendon injury as a result. At the time, Johnson & Johnson reportedly faced around 3,000 similar lawsuits. According to a status conference update from July 2014, there are currently 297 cases pending in the Levaquin multidistrict litigation, with approximately 100 of those already settled and awaiting paperwork and/or finalization.

So far, two Levaquin lawsuits of a reported 2,500 pending claims have made their way to court. One was found in favor of the plaintiff while the other was found in favor of Johnson & Johnson. The first lawsuit resulted in a $1.8 million award to a 76-year-old man who alleged he ruptured both Achilles tendons and lost his ability to play golf and walk through malls. The man said three days after taking Levaquin he felt a stabbing pain in his ankles. A jury found Levaquin to blame.

In June 2011, however, a jury found in favor of Johnson & Johnson in a Levaquin lawsuit after determining that the company properly warned about the risks associated with the antibiotic.

All federal Levaquin lawsuits have been consolidated in an MDL before Judge John R. Tunheim in the U.S. District Court for the District of Minnesota. In December 2011 Oregon resident Diane K. Eccles filed a Levaquin side effects lawsuit and joined the MDL litigation. As of November 2011 over 1,600 Levaquin side effects lawsuits are currently pending in the MDL, and that number is increasing.

In 2008, Public Citizen filed a petition with the FDA, requesting that stronger warnings be issued regarding Levaquin tendon rupture side effects. The consumer protection group then filed a federal lawsuit asking the court to require the FDA to act on their petition-- requesting that new warnings be added about side effects of antibiotics--in accordance with the Administrative Procedure Act.

In July 2008 The Food and Drug Administration (FDA) ordered the Levaquin manufacturer to add a black box warning on the Levaquin label--after it had been associated with tendinitis and ruptured tendons.

The FDA warning states: "Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin."

In 2011 another black box warning was required to be added to the packaging of the antibiotics, warning that the drugs could worsen myasthenia gravis symptoms, which is a condition that causes muscle weakness and difficulty breathing when the chest wall muscles are affected.

Signs & Symptoms of Tendon Rupture

The tendon most frequently associated to the Levaquin induced ruptures is the Achilles tendon, however Levaquin has also been linked to tendon ruptures in the rotator cuff (shoulder), the biceps, the hand, and the thumb. Symptoms often associated with an Achilles tendon rupture are:

• sudden and severe pain
• swelling and bruising
• difficulty walking

Signs & Symptoms of Tendinitis

Symptoms of tendinitis that are produced near a joint aggravated by movement include the following:

• Pain
• Tenderness
• Mild swelling, in some cases

Tendinitis in various locations in your body produces these specific types of pain:

• Tennis elbow causes pain on the outer side of your forearm near your elbow when you rotate your forearm or grip an object.
• Golfer's elbow causes pain on the inner part of your elbow.
• Achilles tendinitis causes pain just above your heel.
• Adductor tendinitis causes pain in your groin.
• Patellar tendinitis causes pain just below your kneecap.
• Rotator cuff tendinitis causes shoulder pain.

Tthe FDA approved the first generic versions of Levaquin in tablet, oral solution and injectable solutions. Among the companies that have applied for generic levofloxacin are Akorn, Aurobindo Pharma, Dr. Reddy's Laboratories, Glenmark Generics, Hi-Tech Pharmacal, Lupin, Mylan, Sagent Strides, Sandoz, Teva, Torrent Pharmaceuticals and Wockhardt.

This video, produced by the FDA, warns patients and physicians of Levaquin tendon injuries and tendon ruptures.



Levaquin is still one of J&J' biggest selling drugs. According to IMS Health, in 2010 Levaquin generated $1.5 billion in sales for the drug company.

Levaquin Peripheral Neuropathy Legal Help

If you or a family member have used Levaquin and have suffered from Levaquin related peripheral neuropathy, you may be entitled to compensation. Please click the link below to send your complaint to a Levaquin lawyer who will review your claim at no cost or obligation.
Last updated on Oct-23-14