Levaquin Complaint can be Amended to Include FDA Warning, Court Says

In May 2016, the U.S. Food and Drug Administration (FDA) warned about the risks of fluoroquinolone antibiotics, which include Levaquin, Avelox and Cipro. The agency said that, given the risk of potentially permanent side effects, these medications should only be used in situations where no other treatment options are available for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections.

Fluoroquinolones are the subject of a multidistrict litigation (MDL) underway in Minnesota. A court recently ruled that plaintiffs can amend the Master Complaint to include this most recent FDA announcement. At least 484 lawsuits have been filed over Levaquin, Cipro and Avelox in the District of Minnesota. An additional 40 lawsuits have been filed in state courts.

Last November, an FDA Advisory Committee found that the risks of fluoroquinolones outweighed the benefits in patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections. The committee reviewed new safety information involving two or more side effects occurring at the same time.

According to the FDA, the potentially permanent side effects can affect tendons, muscles, joints, nerves and central nervous system. These risks apply whether the drugs are taken orally or as injectables. The agency required a label update to reflect this information.

The FDA recently followed up on its May announcement, stating it approved updated safety labels for fluoroquinolones. “Fluoroquinolones have risks and benefits that should be considered very carefully,” Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”

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