FDA Issues Highest Warning on Fluoroquinolone Antibiotics

July 27th, 2016

By Gary Evans, AHC Media Senior Staff Writer,

Clinicians should not prescribe systemic fluoroquinolone antibiotics to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, the Food and Drug Administration urges.

In a drug safety communication issued July 26, 2016 the FDA updated warnings on on the following fluoroquinolones due to disabling side effects:

• Avelox (moxifloxacin)

• Cipro (ciprofloxacin)

• Cipro extended-release (ciprofloxacin extended-release)

• Factive (gemifloxacin)

• Levaquin (levofloxacin)

• Ofloxacin (generic brand)

The FDA approved changes to the labels of fluoroquinolones taken by mouth or injection, saying “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 agency revised its strongest warning – the Boxed Warning – and updated other parts of the drug labels.

“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,” the FDA stated.

Though not mentioned by the FDA, the action could reduce Clostridium difficile infections, which can establish in the gut after administration of fluoroquinolones and other antibiotics