Because the risk of some serious events generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, officials with the US Food and Drug Administration (FDA) have determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options. 

For some serious bacterial infections, including anthrax, plague and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option, FDA officials wrote in a statement released this week. 

Officials with the FDA have approved safety labeling changes for fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections, according to the statement. The labeling changes include an updated Boxed Warning and revisions to the Warnings and Precautions section of the label about the risk of disabling and potentially irreversible adverse reactions that can occur together. 


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“Fluoroquinolones have risks and benefits that should be considered very carefully,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research said in a press release about the recommendations. “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.”

While fluoroquinolones drugs are effective in treating serious bacterial infections, an FDA safety review noted that both oral and injectable fluroquinolones are associated with disabling adverse events involving tendons, muscles, joints, nerves and the central nervous system. These events can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.

The FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In August 2013, the agency required updates to the labels to describe the potential for irreversible peripheral neuropathy.

In November 2015, an FDA Advisory Committee discussed the risks and benefits of fluoroquinolones for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections based on new safety information. The new information focused on two or more side effects occurring at the same time and causing the potential for irreversible impairment. The advisory committee concluded that the serious risks associated with the use of fluoroquinolones for these types of uncomplicated infections generally outweighed the benefits for patients with other treatment options.

The action this week follows a May 12, 2016, drug safety communication advising that fluoroquinolones should be reserved for these conditions only when there are no other options available due to potentially permanent, disabling side effects occurring together. 

FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive). 

Reference

FDA News Release. FDA updates warnings for fluoroquinolone antibiotics. Press release; 2016.