|Articles|September 16, 2019

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

Between July and August 2016, a decrease of 10.4 days of therapy per 1000 patient days (7.6%; P = .002) was observed.

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.”


Related to this article

This Week's Top 5 Infectious Disease News Stories: September 12-September 18, 2026
In this week's top infectious disease stories, a Pennsylvania teen became the state's fourth measles death in weeks, the CDC reported a 17% summer surge in rabies exposure calls, new research revisited whether cefepime raises mortality risk, a multihospital review examined ceftriaxone's safety after state alerts, and examining Legionella pneumonia diagnostics.
Ceftriaxone Safety: Separating Signal From Risk
A retrospective multihospital study found that severe adverse events occurred at similarly low rates with ceftriaxone and other IV cephalosporins suggesting there is no evidence to support avoiding ceftriaxone despite recent health department safety alerts.
Treatment of Latent Tuberculosis in a Trice
A retrospective study of 225 patients across Cook County Department of Health clinics found that the novel 1-month 1HP regimen (isoniazid plus rifapentine) for latent TB infection had a completion rate comparable to standard longer regimens and was well tolerated, suggesting it may be a viable shorter alternative.
Drawing Borders Around a Borderless Specialty
Editor in chief Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS, discusses the proposed OMB rule restricting federal grants for international research collaboration, and how it threatens infectious disease medicine's inherently borderless surveillance networks, publication access, and knowledge-sharing systems.
Beyond Approval: Finding the Right Place for Emerging Gram-Negative Antibiotics
The expanding gram-negative antibiotic pipeline offers important new treatment options; however, FDA approval alone does not define a drug’s place in therapy. Clinicians must weigh the clinical problems that each agent solves, the strength of the evidence behind it, and what remains unknown before incorporating these therapies into routine practice.