The FDA Changed The Labeling For The Drug Tequin. The FDA ( U.S. Food and Drug Administration ) has changed labeling for Tequin ( Gatifloxacin ), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.
The labeling changes update the prescription information as a result of continued reports of serious cases of hypoglycemia and hyperglycemia in patients receiving Tequin.
Life-Threatening Events In 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.
Prescribing information has been revised to include a Contraindication in diabetic patients due to serious reports of hypoglycemia and hyperglycemia ( dysglycemia ).
Additionally, the Warnings and Precautions sections have been updated to identify other risk factors for dysglycemia ( older age, renal insufficiency, concomitant glucose-altering medications ) while taking the drug, and include a recommendation for close medical monitoring.