Bristol Myers Squibb has warned against the use of Tequin (gatifloxacin), an antibiotic dug, in diabetic patients.
The recent changes in labelling strengthen the existing warning on hypoglycaemia (low blood sugar) and hyperglycaemia (high blood sugar) and add a contraindication for use in diabetic patients. The label changes includes information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin, according to the FDA release.
The US FDA will continue monitoring Tequin's safety to ensure that its benefits outweigh the risks to patients.
Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes, added the release.
Tequin is indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhoea, and various infections including infections of urinary tract, kidneys, and skin.