Drugs

Fluoroquinolone Antibiotic Warnings Updated

FDA says it has approved safety labeling changes for fluoroquinolone antibiotics 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. An agency news release says that while the drugs are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves, and the central nervous system. “These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent,” the agency says.

FDA says that because the risk of serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, it has determined that fluoroquinolones should be reserved for use in patients with those conditions who have no alternative treatment options. For some serious bacterial infections, it says, 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.

The labeling changes include an updated Boxed Warning and revisions to the labels’ Warnings and Precautions sections about the risk of disabling and potentially irreversible adverse reactions that can occur together. The label also contains new limitation-of-use statements to reserve the drugs for patients who do not have other available treatment options for acute bacterial sinusitis, exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.

FDA approved fluoroquinolones include Janssen’s Levaquin (levofloxacin), Bayer’s Cipro (ciprofloxacin), ciprofloxacin extended-release tablets, Bayer’s Avelox (moxifloxacin), ofloxacin, and LG Life Science’s Factive (gemifloxacin).

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