FDA Updates Warnings for Fluoroquinolone Antibiotics

Risks outweigh benefits in certain patients

The FDA has approved safety labeling changes for fluoroquinolones antibiotics to enhance warnings about their association with disabling and potentially permanent adverse effects and to limit their use in patients with less-serious bacterial infections.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, MD, director of the Office of Antimicrobial Products at the FDA’s Center for Drug Evaluation and Research. “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 are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluoroquinolones are associated with disabling adverse effects involving tendons, muscles, joints, nerves, and the central nervous system. These effects can occur hours to weeks after exposure to fluoroquinolones and may be permanent.

Because the risk of these serious adverse effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections (UTIs), the FDA has 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, the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option, the agency says.

FDA-approved fluoroquinolones include levofloxacin (Levaquin, Janssen), ciprofloxacin (Cipro and Cipro XR, Bayer Healthcare/Schering-Plough), moxifloxacin (Avelox, Bayer Healthcare/Merck), ofloxacin (Floxin, Ortho-McNeil), and gemifloxacin (Factive, Oscient Pharmaceuticals).

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 events that can occur together. The label also contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated UTIs. The medication guide that is required to be given to patients with each fluoroquinolone prescription describes the safety issues associated with these medications.

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 UTIs based on new safety information. The new information focused on two or more adverse events occurring at the same time and causing the potential for irreversible impairment. The advisory panel 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.

Source: FDA; July 26, 2016.