FDA Drug Safety Communication - Updated Warnings for Oral and Injectable Fluoroquinolone Antibiotics

PUBLISHED: May 11, 2017
Source: Food and Drug Administration
Relevant to: Home Health, Hospital, Medical Office/Clinic, Long Term Care, Ambulatory Care

In July 2016 the US Food and Drug Administration issued a drug safety communication that discussed approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use. These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, the FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.

In that 2016 safety communication the FDA shared its determination that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

This week the FDA shared an update to this safety communication:

  • According to the FDA, patient cases identified by the FDA and findings from published studies currently do no support reports that these medicines may result in detachment of the retina in the eyes, or buldges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection.
  • The FDA is continuing to assess safety issues with fluoroquinolones and will update the public if additional actions are needed.

Follow the link below for additional information or see the StayAlert! Notice published on July 26, 2016.

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