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FDA Updates Warnings for Fluoroquinolone Antibiotics

July 11, 2018

The FDA has announced a required safety label change for fluoroquinolones, according to a press release from the agency. The updated label—that will become more consistent across all labels for all fluoroquinolones taken by mouth or given by injection—will now include stronger warnings about the risks of mental health side effects and serious blood sugar disturbances.

“The use of fluoroquinolones has a place in the treatment of serious bacterial infections—such as certain types of bacterial pneumonia—where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research explained in a statement.

The fluoroquinolone antibiotic class includes a range of mental health side effects that are already described in the Warnings and Precautions section of the drug labeling, however, it currently differs by individual drug. The new class-wide label change will now require that any mental health side effect be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class. The mental health side effects to be included are:

  • disturbances in attention;
  • disorientation;
  • agitation;
  • nervousness;
  • memory impairment; and
  • delirium.

Along with mental health side effects, the FDA also found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia. Because of this, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.

The FDA added the first boxed warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. Then, in February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. Further, in 2016 the warnings were enhanced about the association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system.

“The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” Dr Cox said.

Julie Gould

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