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Safety profile of gatifloxacin questioned; labeling changes made
The antibiotic was associated with an increased risk of both hypoglycemia and hyperglycemia in patients age 66 and older.
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In comparison to other antibiotics, gatifloxacin may be associated with increased health risks – including hypoglycemia and hyperglycemia – in older patients, according to a new study by Canadian researchers.
The researchers, led by David Juurlink, MD, PhD, from the Sunnybrook and Women’s College Health Sciences Center in Toronto, found that gatifloxacin (Tequin, Bristol-Myers Squibb) – typically used to treat conditions such as pneumonia, bronchitis, uncomplicated gonorrhea and various infections – was linked to an increased risk of in-hospital treatments for dysglycemic conditions in patients age >66. This increased risk was seen both in patients with and without diabetes.
Juurlink and his colleagues stressed that the implications of these findings may have a significant effect on treatment practices. “Physicians and pharmacists should be aware of the increased risk of potentially life-threatening glucose abnormalities during gatifloxacin therapy,” the researchers wrote in the New England Journal of Medicine. “Patients treated with gatifloxacin should be instructed to seek medical attention if symptoms of hypoglycemia or hyperglycemia develop.”
The researchers also encouraged doctors to consider treating patients with alternative antibiotics. “Because gatifloxacin offers relatively few therapeutic advantages over alternative antibiotics that confer little or no increased risk of dysglycemia, including other fluoroquinolones, some clinicians may elect to avoid the use of gatifloxacin altogether,” they wrote.
Due to the public health implications of this study, it was published online ahead of the journal’s schedule.
Two trials
The researchers conducted two trials for this study. In the first, the health records of patients aged >66 who were treated in a hospital for hypoglycemia after outpatient treatment with a macrolide or a respiratory fluoroquinolone – such as gatifloxacin, levofloxacin, moxifloxacin or ciprofloxacin – were examined.
The researchers identified 788 patients treated for hypoglycemia within 30 days after antibiotic therapy. More than 90% of these patients had known diabetes; their average age was 78. The researchers found that compared with patients treated with macrolide antibiotics, patients treated with gatifloxacin were about four times more likely to require treatment for hypoglycemia. There was no increased risk among patients treated with moxifloxacin, ciprofloxacin or cephalosporins.
In the second trial, the researchers examined health records of patients aged >66 who received hospital care for hyperglycemia. For each patient, health records of as many as five control patients were also examined. The control patients were well-matched for age, gender, the presence or absence of diabetes and the timing of antibiotic therapy.
For this trial, the researchers identified 470 patients treated for hyperglycemia within 30 days after antibiotic therapy. About 62% of these patients had diabetes, and their average age was 77.4. Patients who required in-hospital treatment for hyperglycemia were almost 17 times more likely to have recently been treated with gatifloxacin. In contrast, the researchers found no increased risk of hyperglycemia in patients treated with other fluoroquinolones or second-generation cephalosporins.
The risk of both hypoglycemia and hyperglycemia with gatifloxacin treatment was seen regardless of the presence or absence of diabetes. For the two trials, the health records of about 1.4 million patients were examined.
New labeling
Following the increased concerns over the safety profile of gatifloxacin, Bristol-Myers Squibb announced labeling changes for the antibiotic.
The labeling changes were announced in a letter to health care professionals and include a contraindication in patients with diabetes and warnings about the risks of hypoglycemia and hyperglycemia.
The new labeling also identifies other risk factors associated with the development of hyperglycemia or hypoglycemia during treatment with gatifloxacin, including advanced age, renal insufficiency and concomitant glucose altering medications. Additionally, the new labeling includes a recommendation for close medical monitoring.
The FDA said it will continue monitoring the safety of gatifloxacin to ensure that its benefits outweigh the risks to patients.
Theodore Eickhoff, MD, an infectious disease expert and professor of medicine at the University of Colorado Health Sciences Center, said doctors should be cautious about prescribing gatifloxacin to patients. “I would recommend avoiding the use of the drug, especially in elderly patients at risk,” he told Endocrine Today. “I also think that a ‘black box’ warning for gatifloxacin from the FDA is in order.”
For more information:
- Park-Wyllie L, Juurlink D, Kopp A, et al. Outpatient gatifloxacin therapy and dysglycemia in older adults. N Engl J Med. 2006;354.