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FDA Strengthens Warning on Fluoroquinolone Antibiotics

Jul 12, 2016

The warning label on fluoroquinolone antibiotics, which includes the brand names Levaquin, Cipro, and Avelox, has been revised. The U.S. Food and Drug Administration (FDA) points out that the risks outweigh the benefits in patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections (UTIs) who can be treated with other medications. According to the safety alert, patients with these conditions should only be treated with fluoroquinolones if no alternative treatments are available.

The notification warns that, "fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system." The FDA updated the label based on the findings of an internal safety review. The FDA previously updated the warning label on fluoroquinolones in 2013 to warn about the risk of peripheral neuropathy.

Side effects associated with fluoroquinolones may include tendon, joint and muscle pain, a "pins and needs" tingling or pricking sensation, confusion and hallucinations. If patients taking the drugs experience these symptoms, the FDA advises them to contact their health care professionals.

Levaquin is a fluoroquinolone approved in 1996. It was named in over 3,400 lawsuits by 2010. In a 2012 interview with The New York Times, pharmacological epidemiologist Dr. Mahyar Etminan found "that the risk of suffering potentially blinding retinal detachment was nearly fivefold higher among current users of fluoroquinolones . . . and [there was] a significantly increased risk of acute kidney failure."

Levaquin was also the subject of a lawsuit filed against former FDA Commissioner Margaret Hamburg, alleging she conspired to ensure Levaquin was approved for personal financial gain. The lawsuit contends that she helped approve the drug because she and her husband had large stakes in J&J, which manufactured Levaquin. Allegedly, Levaquin has been linked to 5,000 deaths.

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