FDA Updates Warning Label on Fluoroquinolone Antibiotics

The U.S. Food and Drug Administration (FDA) is updating the drug labels on all fluoroquinolone antibiotics, warning that its use should be restricted to certain uncomplicated infections. According to the safety alert, the agency says the risks of the drugs outweigh the benefits in patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who can be treated with other medications. Fluoroquinolones should only be used in patients with these conditions if no other treatment options are available, the FDA said.

The FDA said 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 alert was based on findings from an FDA safety review. The FDA is updating drug labels and Medication Guides to reflect this information.

Patients are advised to contact their health care professionals if they experience side effects associated with fluoroquinolones, including tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.

Last year, an FDA panel called for a stronger warning label on fluoroquinolones, which include the brand name drugs Levaquin, Cipro and Avelox. In 2013, the FDA updated the warning label to warn about the risk of peripheral neuropathy.

Levaquin was introduced in 1996. By 2010, it was named in over 3,400 lawsuits. 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.”

A federal lawsuit was recently filed against former FDA Commissioner Margaret Hamburg. The suit alleges she conspired to get Levaquin approved for personal financial gain; according to the suit she and her husband had large stakes in J&J, who manufacturers Levaquin. The lawsuit alleges that Levaquin has been implicated in 5,000 deaths. Hamburg’s attorneys deny the allegations, stating they expect the suit to be dismissed.

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