Levaquin, or levofloxacin, belongs to a class of medications known as fluoroquinolone antibiotics. Marketed by a subsidiary of Johnson & Johnson, Levaquin was first approved for U.S. sale in 1996. The drug is now used by millions of Americans every year to treat bacterial infections ranging from urinary tract infections to respiratory illnesses like pneumonia or bronchitis. Before the first generic versions of levofloxacin were approved, Levaquin generated $1.3 billion in annual sales for Johnson & Johnson.

Breaking Levaquin News: FDA Says Fluoroquinolones Too Dangerous for Uncomplicated Infections

The U.S. Food & Drug Administration (FDA) is warning that the risks associated with Levaquin and other fluoroquinolone antibiotics, including serious complications affecting the nerves, muscles, tendons and central nervous system, make it too dangerous for patients with certain uncomplicated infections. According to an alert issued in May 2016, the medication should be restricted in those patients unless other treatments are not an option.  The drugs’  will be updated with a new boxed warning. Read More

Levaquin Side Effects

People who take Levaquin should be aware of the drug’s potential complications, and contact their doctor should they experience any of the following problems:

    • Tendon Damage: The Levaquin label has includes a black box warning regarding its potential to cause serious tendon damage. Patients over the age of 60, those taking steroids, or those who have had kidney, heart or lung transplants are most likely to experience this potentially debilitating side effect. Patients using Levaquin should call their doctor right away at the first sign of tendon pain, swelling or inflammation. Patients should also be aware that this complication may occur several months after treatment with Levaquin has ended.

levaquin neuropathy

  • Peripheral Neuropathy and Permanent Nerve Damage: In 2004, new information regarding a potential for peripheral neuropathy and permanent nerve damage was added to the “Warning and Precautions” section of the Levaquin label. In 2013, however, the U.S. Food & Drug Administration (FDA) ordered the manufacturers of Levaquin and other fluoroquinolones to strengthen peripheral neuropathy warnings, after determining that the labels did not adequately describe the risk of rapid onset and potential for permanent nerve damage. Symptoms of Levaquin peripheral neuropathy can occur shortly after the initiation of treatment with either oral or intravenous forms of the antibiotic. Patients should consult their doctor if they experience any pain, burning, numbness, tingling, or weakness in their extremities, or any changes in the way they experience touch, pain or temperature.
  • Levaquin Eye Injury: A study that appeared Journal of the American Medical Association (JAMA) in January 2012 suggested patients treated with fluoroquinolones were five times more likely to suffer a retinal detachment, in which the retina peels away from its underlying layer of support.

Levaquin Litigation

By 2012, more than 3,400 Levaquin lawsuits had been filed on behalf of plaintiffs who allegedly experienced tendon damage due to its use. These included about 1,900 cases that had been filed in a federal multidistrict litigation in the District of Minnesota, and another 1,500 in New Jersey Superior Court. By May 2014, all but about 340 of those claims had been settled.

As of July 2015, dozens of Levaquin lawsuits and other fluoroquinolone cases had been filed in U.S. courts on behalf of patients who allegedly suffered permanent nerve damage and peripheral neuropathy related to their use of the antibiotics. All of the plaintiffs involved in these cases accuse the drugs’ manufacturers of failing to adequately warn patients and doctors about these possible complications.

  1. FDA (2013) “Levaquin Medication Guide” http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
  2. FDA (2013) “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection.” http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm.
  3. JAMA (2012) “Oral  Fluoroquinolones and the Risk of Retinal Detachment” http://jama.jamanetwork.com/article.aspx?articleid=1148331
Last Modified: May 19, 2016

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