Levaquin Plaintiffs Allowed to Include Updated FDA Safety Warnings in Legal Complaints

Hundreds of product liability lawsuits involving the fluoroquinolone antibiotics Levaquin, Cipro and Avelox are moving toward trial in a multidistrict litigation (MDL) in the U.S. District Court, District of Minnesota.

In June 2016, the court granted a motion from the plaintiffs to amend the master complaint to include information about the U.S. Food & Drug Administration’s (FDA) May 2016 safety announcement for fluoroquinolone antibiotics. The court said that doing so would not greatly expand the scope of the proceedings.

Levaquin (levofloxacin), Cipro (ciprofloxacin), and Avelox (moxifloxacin) belong to the fluoroquinolone class of antibiotics. Drugs in the fluoroquinolone family are used to treat a wide range of bacterial infections, including staph, pneumonia, urinary tract infections, E. coli and salmonella. Cipro is sometimes given to people who have been exposed to anthrax.

Fluoroquinolones are intended to treat serious bacterial infections, but are often prescribed for non-life threatening conditions such as earaches, bronchitis, sinusitis, and other illnesses that could be treated with lesser drugs. The widespread use of fluoroquinolones has led to bacterial resistance to the drugs. Patients with less severe infections have been at risk for serious side effects when they did not have to be.

In May 2016, the FDA ordered an update to fluoroquinolone labels to warn that the risks posed by the drugs outweigh their benefits for patients with uncomplicated infections for whom other treatment options are available. An FDA review confirmed that fluoroquinolone antibiotics are linked to a range of serious side effects, involving tendons, muscles, joints, nerves, and the central nervous system. Levaquin, in particular, has been linked to tendon damage, especially to ruptures of the Achilles tendon. Fluoroquinolone complications are potentially permanent and they can occur together, the FDA said.

One complication is peripheral neuropathy, a serious nerve disorder that can result in permanent disability. Symptoms include pain, burning, tingling, numbness, and weakness. Peripheral neuropathy can occur during or even after fluoroquinolone treatment. The condition can last months to years or can even be permanent, according to the FDA.

The risk for peripheral neuropathy was first noted on fluoroquinolone labels in 2004. In 2013, the FDA ordered the warning strengthened to note the possible rapid onset of symptoms and the potential for permanent nerve damage. Plaintiffs in the MDL claim that the manufacturers of Levaquin, Cipro and Avelox failed to provide doctors and patients with adequate warnings about the potential for fluoroquinolones to cause the disorder.

The minutes from the June status conference indicate that there are at least 484 peripheral neuropathy lawsuits involving Levaquin, Cipro and Avelox in the District of Minnesota, with 40 additional cases filed in state courts around the country. Plaintiffs are seeking compensation for medical bills, lost wages, pain and suffering, and other damages.

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