A label change by FDA reduces misuse of antibiotic, study shows

April 23, 2021

The U.S. Food and Drug Administration (FDA) in 2016 took action to reduce the overuse of fluoroquinolones, a type of antibiotic associated with serious side effects. That step helped cut the use of these antibiotics for uncomplicated urinary tract infections, or UTIs, by more than half, according to a University of Florida study published in JAMA Internal Medicine as reported in a news release.

Fluoroquinolones, the most common class of quinolones, became one of the world’s most widely used antibiotics in the 1990s, but concerns about serious side effects emerged in the 2000s. The FDA warned about the risk of tendon ruptures and severe nerve damage, but the drug’s use for uncomplicated infections, for which there are safer alternatives, continued.

Almut Winterstein, PhD, Professor and the Dr. Robert and Barbara Crisafi Chair of Pharmaceutical Outcomes and Policy in the UF College of Pharmacy and Director of the UF Center for Drug Evaluation and Safety, participated in a 2015 FDA advisory committee meeting that re-evaluated the risk-benefit of quinolones. Instead of banning the drug, which proves useful in cases of severe infection and antibiotic resistance, the committee supported the removal of labeling indications for uncomplicated UTIs, acute sinusitis and acute exacerbations of chronic obstructive pulmonary disease, or COPD.

In the recent study, Winterstein and her research team evaluated the effect of this decision. “The effect of regulatory action on prescribing behavior can vary tremendously,” she said. “For example, previously issued box warnings to alert prescribers about the serious side effects of quinolones had limited effect. Our study aimed to find out whether the FDA’s action resulted in a shift in prescribing practice, and it did.”

In 2015, quinolones were used to treat 41.6% of antibiotic-treated UTIs. When the relabeling policy went into effect in 2016, the number immediately dropped by 7.2% and ultimately decreased to 19.2% by the end of 2018. Prevalence of quinolone treatment for sinusitis dropped from 8.3% to 2.9% and 31.9% to 14.6% for COPD.

Treatment mostly shifted to recommended antibiotics: nitrofurantoin for UTIs, amoxicillin for sinusitis and macrolides for COPD. However, use of non-recommended antibiotics like tetracycline for COPD also increased.

Visit University of Florida for more news