Systemic fluoroquinolones* (FQ) currently in use include ciprofloxacin, levofloxacin, moxifloxacin, gemifloxacin, delafloxacin and ofloxacin.   These agents have a number of FDA-approved indications including respiratory tract, genitourinary tract, skin and soft-tissue, intraabdominal, and gastrointestinal tract infections.

Because of ongoing safety concerns with FQ use, the FDA issued drug safety communications associated with systemically administered FQ in July 2008, August 2013, and May 2016.  The latest drug safety communication advised prescribers against the use of FQ for treatment of acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections when other antibiotic options are available.  This is due to association of fluoroquinolones to disabling and potentially permanent serious side effects involving the tendons, muscles, joints, nerves, and central nervous system.  As a result, drug labels for all systemic fluoroquinolones were updated to reflect this new safety information.

In light of the most recent FDA drug safety communication, a study published online in Clinical Infectious Diseases on January 24th examined and characterized FQ prescribing in US adults after ambulatory clinic visits over a 1 year period.  The study investigators found that 31.5 million courses of FQ were dispensed to adults in 2014.  Genitourinary infections were the most common reasons for FQ use, accounting for 24.5% or 7.7 million prescriptions.  Conditions in which FDA advised against the routine use of FQ when alternative options exist totaled 7.1 million or 22.5% of FQ prescriptions (4.7 million for uncomplicated urinary tract infections, 1.5 million for sinusitis, and 0.85 million for bronchitis).  The authors concluded that with the threats of antibiotic resistance and patient safety concerns, antimicrobial stewardship efforts should be directed toward reducing the staggering amount of unnecessary FQ use.

Although this study focus on ambulatory care settings, opportunities frequently exist to improve the use of fluoroquinolone use in hospital and long-term care settings.  In order to reduce the use of fluoroquinolones in all health care settings, prescribers should consider the following:

– For acute bronchitis, antibiotic should generally not be prescribed unless there is a concern for pneumonia

– For uncomplicated urinary tract infections, current IDSA guideline recommends the use of nitrofurantoin, sulfamethoxazole/trimethoprim, or fosfomycin over fluoroquinolones

– For acute sinusitis, antibiotic should ONLY BE PRESCRIBE IF symptoms are severe (fever ≥39°C or ≥102°F accompanied by purulent nasal drainage or facial pain) lasting >3-4 days; have persisted for >10 days without improvement; or have worsened after initial improvement

– If antibiotic is needed for acute sinusitis, amoxicillin-clavulanate is the preferred antibiotic.  Doxycycline or a respiratory flouroquinolone (levofloxacin, moxifloxacin) can be used as alternative therapy for patient with penicillin allergy

– If a systemic fluoroquinolone must be used, the shortest possible duration of therapy, and appropriate dose and frequency based on organ function should be prescribed

For additional details regarding the study, please click here to find out more.

*Trovafloxacin, gatifloxacin, and sparfloxacin are other members of the fluoroquinolone class of antibiotics that have been withdrawn from the market due to a variety of serious adverse events including hepatotoxicity, dysglycemia (hypo- or hyper-glycemia), QT prolongation and phototoxicity.

Written by Phil Chung, PharmD, MS, BCPS