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Adding another in a series of label warnings for fluoroquinolones, the FDA is emphasizing that the antibiotics pose too high a risk of patient harm to be used for relatively minor infections.
These include acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, the FDA stated.1
Fluoroquinolones should be used in such cases only if the patient has no other treatment option, the agency explained.
The FDA emphasized the risks of mental health effects and serious blood sugar disturbances related to the antibiotics in a July 10, 2018, warning, which applies to both oral and injectable formulations.
“The new class-wide labeling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class,” the FDA stated.
“The mental health side effects to be included in the labeling across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium.”
Additionally, the recent FDA review reported cases where patients on fluoroquinolones experienced hypoglycemia.
“As a result, 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 stated.
This latest action follows the FDA’s 2016 enhanced warnings about the link between fluoroquinolone use and damage to tendons, muscles, and joints.
This risk was underscored by a recent CDC guest blog written by Rachel Brummert, BS, MS, president of Patient Safety Impact. Brummert suffered multiple tendon ruptures after being on fluoroquinolones.
“In addition, I suffer from central and autonomic nervous system damage. This damage is permanent,” she wrote.2
She also attributed fluoroquinolone use to memory loss, chronic pain, and low blood pressure.
“I never knew that an antibiotic, which I thought was supposed to help me feel better, could cause an otherwise healthy person like myself to become disabled at 36 years old,” Brummert notes.
The FDA said that appropriate fluoroquinolone use is still a mainstay treatment for patients.
Part of the problem is that the antibiotics are being prescribed when they are indicated for first-line therapy and even in cases where treatment is not needed at all.
According to the FDA,1 currently approved fluoroquinolones include levofloxacin, ciprofloxacin, ciprofloxacin extended-release tablets, moxifloxacin, ofloxacin, gemifloxacin, and delafloxacin.
Financial Disclosure: Peer Reviewer Patrick Joseph, MD, reports that he is a consultant for Genomic Health Reference Laboratory, Siemens Clinical Laboratory, and CareDx Clinical Laboratory. Senior Writer Gary Evans, Editor Jesse Saffron, Editor Jill Drachenberg, Nurse Planner Patti Grant, RN, BSN, MS, CIC, and Editorial Group Manager Terrey L. Hatcher report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.