Study links FDA warnings to fewer prescriptions for fluoroquinolones


A new study suggests that warnings from the Food and Drug Administration (FDA) about adverse events related to fluoroquinolone antibiotics may have helped reduce drug prescribing, but not all doctors have responded to the warnings.

The study, published this week in JAMA network open, examined data from more than 1.2 million Medicare patients who received fluoroquinolones and found that the overall prescription of fluoroquinolones began to decline significantly in the 31 months prior to the FDA issuance of a warning on fluoroquinolones in 2013. The decline continued at a slower pace after the 2013 and 2016 warnings.

Decreases in fluoroquinolone prescriptions after the warnings have only been observed in certain types of physicians.

Several warnings from the FDA

Fluoroquinolones are a class of broad-spectrum antibiotics used to treat a variety of common bacterial infections. Since their approval in the late 1980s, they have become one of the most commonly prescribed classes of antibiotics. But in recent years, the FDA has issued several warnings in response to adverse events related to fluoroquinolone treatment.

In 2008, the FDA added a black box warning that the use of fluoroquinolones was associated with an increased risk of tendonitis and tendon rupture. This was followed by the 2013 label update, which warned that fluoroquinolones could cause irreversible damage to peripheral neuropathy, a nerve disease that can cause weakness, numbness, and pain in the hands and the feet.

In 2016, the FDA revised the black box warning to further address these adverse events, recommending that patients with acute sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infection (UTI) only use fluoroquinolones if no other treatment option is available. Since then, the FDA has issued additional warnings about the potential risks of mental health side effects, blood sugar disorders, aortic aneurysm and dissection.

To analyze changes in prescribing after FDA warnings in 2013 and 2016, a team led by researchers at the University of Minnesota looked at administrative claims data from a 20% random sample of compensation recipients. to the Medicare Act from January 1, 2011 to December 31. , 2017.

The cohort consisted of over 1.2 million unique patients (68.5% female, mean age 69.7 years) with a diagnosis of sinusitis, bronchitis or uncomplicated urinary tract infection. The researchers also obtained data on 170,938 physicians who prescribed fluoroquinolones during the study period and their organizations.

Using interrupted time series analysis, researchers compared the levels and prescribing trends of fluoroquinolones over the 31 months leading up to the 2013 warning (baseline period), every month after the warning. FDA 2013 (post-warning period 1) and every month after Warning 2016 (post-warning period 2). They then looked at the association between the levels and trends in prescribing fluoroquinolones and the status of each physician, as well as the type of organization in which they practiced.

The analysis found a significant drop in the prescription of fluoroquinolones prior to the 2013 warning, with a downward trend of 0.18 percentage points per month (95% confidence interval [CI], -0.19 to -0.18; P

The decline continued after the warnings of 2013 and 2016, but more slowly. Immediate prescription levels of fluoroquinolones in the post-alert 1 period increased by 3.42 percentage points (95% CI: 3.23 to 3.62; P P

Compared to the baseline period, the trend for prescribing fluoroquinolones increased by 0.08 percentage points per month (95% CI, 0.08 to 0.10; P P

Variations in physician response

In their analysis of prescribing characteristics by physician, the researchers found that the prescription levels of fluoroquinolones among physicians affiliated with a hospital with a top 10th percentile case mix index fell by 1.13 percentage points (CI at 95%, –1.92 to –0.34; P= 0.005) compared to those without such an affiliation in the post-alert period 1, while levels for primary care physicians (PCP) decreased by 1.34 percentage points (95% CI, -1, 78 to -0.88; P

Doctors at teaching hospitals were the only ones to show a declining trend in prescribing in the post-alert period 1.

“Despite repeated warnings, some doctors did not respond to the recommendations,” wrote the study authors. “Although PCPs have shown a general decline in prescribing trends compared to non-PCPs, they have not shown a different change in behavior after the warnings, perhaps because many PCPs mistakenly believed that fluoroquinolones were more appropriate for treating symptoms of uncomplicated UTI than the first recommendation. – line therapies for this condition. “

The authors point out that the observed decline in fluoroquinolone prescribing may also reflect antibiotic management measures that specifically targeted inappropriate fluoroquinolone prescribing.

“Such efforts, in conjunction with warnings from the FDA, could explain part of the decline in prescribing behavior over the study period as well as the specific changes in prescribing rates associated with certain characteristics of physicians,” said they wrote.

The authors say the findings could help identify certain medical and organizational characteristics associated with prescribing fluoroquinolones, which could ultimately lead to more targeted strategies to promote fluoroquinolone de-adoption and improve patient safety.


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