FDA warns against routine fluoroquinolone use



The U.S. Food and Drug Administration has issued a warning to health care providers against the routine prescribing of fluoroquinolone antibiotics to those patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.

After conducting a safety review of the drugs, the FDA concluded that fluoroquinolone should be reserved for those patients who do not have alternative treatment options, in light of the findings that the antibiotics – when used systemically in either tablet, capsule, or injectable form – are associated with “disabling and potentially permanent serious side effects” that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, according to the agency.

The FDA says health care providers should stop systemic fluoroquinolone treatment immediately in patients reporting serious side effects and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course. The drug labels and medication guides for all fluoroquinolone antibiotics will be updated to reflect the new safety information.

The FDA had previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008, and the safety issues described in the current warning were discussed at an FDA Advisory Committee meeting in November 2015.

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