Gatifloxacin Linked to Dangerously High and Low Blood Glucose

The risk of developing serious hyperglycemia was almost 17 times greater for elderly patients who took the antibiotic gatifloxacin (Tequin, Bristol-Myers Squibb) than for those who took another antibiotic, according to two Canadian studies published a month ahead of schedule by the New England Journal of Medicine.¹

In the same population, those who took gatifloxacin were four times more likely to be hospitalized for hypoglycemia.

In analyzing the health care records of more than 1.4 million residents of Ontario, Canada, ≥66 years of age, the researchers found 16,697 cases of gatifloxacin treatment were linked with 178 hospital visits (1.1%) for dysglycemia within 30 days.

“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 conclude.

Gatifloxacin is commonly used to treat infections of the lungs, sinuses, and urinary tract, as well as certain sexually transmitted diseases. It was approved by the Food and Drug Administration (FDA) in 1999.

Bristol-Myers Squibb has discontinued commercial promotion for Tequin in the U.S., according to company spokesperson Eric Miller. However, he says, this decision will not impact the drug's manufacture, distribution, or availability.

“Tequin is generally well tolerated in appropriate patients,” Miller says.

In a February 15 letter to health care professionals, Bristol-Myers Squibb details proposed changes to its prescribing information for gati-floxacin. The new label includes an update of the existing warning about high and low blood glucose, and a contraindication for use in patients with diabetes. The changes identify other risk factors, including “older age, renal insufficiency, and concomitant glucose-altering medications (particularly hypoglycemic medications).”

In an accompanying editorial, Jerry H. Gurwitz, MD, executive director of the Meyers Primary Care Institute at the University of Massachusetts in Worcester, notes that the new warnings for gatifloxacin were not deemed to require a black box, “a decision that probably warrants reconsideration in view of the findings reported.”²

“The drug's place among the broad-spectrum antibiotics available for outpatient use is tenuous at best,” Gurwitz continues. “There are safer, equally effective, and less costly alternatives.... This choice should not be a difficult one.” ▪