2016 FDA Warning Cut Down on Fluoroquinolone Use, Increased Uptake of Alternative Agents

In 2016, the US Food and Drug Administration (FDA) issued an update to the initial boxed warning on fluoroquinolones noting that the serious side effects associated with the antibiotics generally outweigh the benefits for patients with certain uncomplicated infections who have alternative treatment options.

A new study published in Infection Control & Hospital Epidemiology sought to analyze antibiotic data from 29 southern United States hospitals over a 5-year period in order to evaluate antibiotic prescribing practices and whether the black box warning had any effect.

Investigators gathered data between January 2013 and December 2017 to estimate monthly hospital-wide inpatient antibiotic use measured by days of therapy per 1000 patient days. Data on 37 different antibiotics were included and categorized by indication, antibiotic class, or as individual agents.

Participating hospitals fell within the Duke University Health System facilities and community hospitals participating in the Duke Antimicrobial Stewardship Outreach Network (North Carolina [n = 18], Georgia [n = 7], Virginia [n = 2], South Carolina [n = 1], and Florida [n = 1].

Over the 60-month study period, the research team examined antibiotic data from 28 community hospitals and 1 academic hospital for a total of 6,685,950 patient days (median hospital size was 214 beds [range, 25—957]).

Each month leading up to the July 2016 FDA announcement, the use of fluoroquinolones decreased by 0.7%, for an overall decrease of ~25% from January 2013 through July 2016. Between July and August 2016, an additional decrease of 10.4 days of therapy per 1000 patient days (7.6%; P = .002) was observed.

“Following the announcement, fluoroquinolone use continued to decline at a similar rate (0.9% per month),” investigators found. “The risk ratio (RR) between July 2016 and the end of the study period (December 2017) was 0.89 (95% confidence interval [CI], 0.79—1.01).”

In turn, the uptake of alternative antibiotics for certain conditions increased over the study period. The rate of prescription for the group of antibiotics commonly used to treat community-acquired infections (cefotaxime, ceftriaxone, and ertapenem) decreased 0.5% per month leading up to the black box fluoroquinolone warning. After the July 2016 advisory, use increased 0.6% per month (RR, 1.24; 95% CI, 1.11—1.38).

The shift to alternatives will require ongoing investigation, the study team reported, as the risk for resistance to alternate agents is a possibility in the future.

“Our study is unique because we examined a more recent period and included inpatient acute-care hospitals,” investigators concluded. “We believe that the decline in fluoroquinolone use was a result of both locally implemented stewardship initiatives and the recognition of the risks of fluoroquinolones by clinicians.”