In the Journals

Fluoroquinolone use decreases following FDA black box warning

Michael E. Yarrington, MD
Michael E. Yarrington

The FDA black box warning on fluoroquinolones that was issued in 2016 resulted in a significant, further decline in use at 29 southeastern U.S. hospitals, according to a recent study published in Infection Control and Hospital Epidemiology.

“This study was prompted by the significant, concerted efforts from our organization to target and reduce fluoroquinolone use across our network of hospitals,” Michael E. Yarrington, MD, a fellow at the Duke Center for Antimicrobial Stewardship and Infection Prevention in Durham, North Carolina, told Infectious Disease News.

The decline observed after the FDA black box warning occurred after a decrease in the use of fluoroquinolones over a period of several months, according to Yarrington and colleagues.

The FDA’s strengthened black box warning advised avoiding fluoroquinolones for uncomplicated infections such as acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections and acute bacterial sinusitis. This followed an initial safety announcement from the FDA in May 2016. Yarrington and colleagues calculated monthly estimates of hospitalwide inpatient antibiotic use between January 2013 and December 2017 in 28 community hospitals and one academic hospital before and after the FDA black box warning to quantify the effect of the update on inpatient antibiotic use.

According to Yarrington, fluoroquinolone use, which the study showed had been steadily declining because of “aggressive stewardship efforts,” dropped significantly following the FDA announcement. The study showed that fluoroquinolone use decreased by 0.7% each month before the FDA announcement, resulting in an approximate 25% decrease from January 2013 through July 2016. Further, a decrease in fluoroquinolone use of 10.4 days of therapy per 1,000 patient days (7.6%, P = .002) was observed between July and August 2016. Researchers found that fluoroquinolone use continued to decrease at a similar rate of 0.09% each month after the the black box warning. Antibiotics frequently used as treatment for community-acquired infections, including cefotaxime, ceftriaxone, and ertapenem, collectively declined by 0.5% per month before the FDA announcement and increased by 0.6% per month (RR = 1.24; 95% CI, 1.11-1.38) after July 2016.

Yarrington believes that there is no reason why “these findings are applicable only to the southern United States.” The same trend, or a similar trend, would be seen on a national level, he continued.

“National drug safety advisories likely play a role in managing antibiotic use in concert with local antibiotic stewardship efforts,” he said. “Monitoring use of targeted antibiotics is critical to understand these effects.” – by Caitlyn Stulpin

Disclosure: Yarrington reports no relevant financial disclosures.

Michael E. Yarrington, MD
Michael E. Yarrington

The FDA black box warning on fluoroquinolones that was issued in 2016 resulted in a significant, further decline in use at 29 southeastern U.S. hospitals, according to a recent study published in Infection Control and Hospital Epidemiology.

“This study was prompted by the significant, concerted efforts from our organization to target and reduce fluoroquinolone use across our network of hospitals,” Michael E. Yarrington, MD, a fellow at the Duke Center for Antimicrobial Stewardship and Infection Prevention in Durham, North Carolina, told Infectious Disease News.

The decline observed after the FDA black box warning occurred after a decrease in the use of fluoroquinolones over a period of several months, according to Yarrington and colleagues.

The FDA’s strengthened black box warning advised avoiding fluoroquinolones for uncomplicated infections such as acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections and acute bacterial sinusitis. This followed an initial safety announcement from the FDA in May 2016. Yarrington and colleagues calculated monthly estimates of hospitalwide inpatient antibiotic use between January 2013 and December 2017 in 28 community hospitals and one academic hospital before and after the FDA black box warning to quantify the effect of the update on inpatient antibiotic use.

According to Yarrington, fluoroquinolone use, which the study showed had been steadily declining because of “aggressive stewardship efforts,” dropped significantly following the FDA announcement. The study showed that fluoroquinolone use decreased by 0.7% each month before the FDA announcement, resulting in an approximate 25% decrease from January 2013 through July 2016. Further, a decrease in fluoroquinolone use of 10.4 days of therapy per 1,000 patient days (7.6%, P = .002) was observed between July and August 2016. Researchers found that fluoroquinolone use continued to decrease at a similar rate of 0.09% each month after the the black box warning. Antibiotics frequently used as treatment for community-acquired infections, including cefotaxime, ceftriaxone, and ertapenem, collectively declined by 0.5% per month before the FDA announcement and increased by 0.6% per month (RR = 1.24; 95% CI, 1.11-1.38) after July 2016.

Yarrington believes that there is no reason why “these findings are applicable only to the southern United States.” The same trend, or a similar trend, would be seen on a national level, he continued.

“National drug safety advisories likely play a role in managing antibiotic use in concert with local antibiotic stewardship efforts,” he said. “Monitoring use of targeted antibiotics is critical to understand these effects.” – by Caitlyn Stulpin

Disclosure: Yarrington reports no relevant financial disclosures.