Posted on April 15, 2016 in: Professional Practice
Fluoroquinolones (FQ) are widely used in both inpatient and outpatient settings to treat pneumonia, urinary tract infections, intra-abdominal infections and others. In 2011, approximately 23 million patients filled outpatient prescriptions for fluoroquinolones and 3.8 million inpatients billed for fluoroquinolones.1 However, given the notable toxicities and development of resistance, there has been a recent effort to restrict their use.
Fluoroquinolone labeling currently contains warnings regarding tendonitis, tendon rupture, central nervous system effects, peripheral neuropathy, myasthenia gravis exacerbation, hepatotoxicity, QT prolongation, Torsades de Pointes, phototoxicity and hypersensitivity amongst other precautions.2 In 2013, the FDA required stricter warning labeling for FQs that highlights the risk of peripheral neuropathy which can last months or be permanent.1 Additionally, some FDA committee members suggested adding the risk of prolonged neuropathy to the Boxed Warning.
Fluoroquinolone related-toxicities garnered so much provider and public attention that a term, fluoroquinolies-associated disability (FQAD), was coined to describe the constellation of symptoms resulting in disability lasting 30 days after the end of treatment. Notably, FQAD cases reported in the FDA Adverse Events Reporting System (FAERS) were not associated more frequently with any one of the three major FQs: moxifloxacin, levofloxacin or ciprofloxacin. Typically FAERS reports are generated by healthcare professionals; however a disproportionate 84% of FQAD cases were reported to the system by the public.3
In addition to heightened awareness of toxicities, poor evidence exists for many indications for which FQs are used. Two FDA Advisory Committees, Antimicrobial Drugs and Drug Safety and Risk Management, overwhelmingly agreed in November 2015 that evidence is lacking for use of FQs as first line therapy in acute bacterial sinusitis, COPD exacerbations and uncomplicated UTI.4 Prescribing practices, however, lag behind the evidence. The question still remains, though, as to what clinicians should be relying on.
Inappropriate use and overuse of antibiotics is a factor in the continued spread of antibiotic-resistant microbes. In order to improve quality of care and lower healthcare costs, antimicrobial stewardship has become a priority. By taking a closer look at FQ pitfalls, we can generate a list of supportive evidence for recommending discontinuation or switching to therapy as appropriate.
Knowing the risks that accompany FQ use is important. The public grows increasingly more aware and wary of FQ-related toxicities. Not only are FQs making their way into national news, but social media is also impacting public opinion with the emergence of a multitude of support groups for affected patients (who often refer to themselves as "Floxies"). Being well-versed in the appropriate indications and the relative risks and benefits of FQs will help us best assist patients and providers in making informed, and individualized therapy decisions.