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 Stronger warnings for antibiotic Tequin

ROCKVILLE, Md., Feb. 16 (UPI) -- The Food and Drug Administration said Monday Bristol-Myers Squibb has bolstered its warnings for Tequin(gatifloxacin).

The revised labeling on the antibiotic notifies healthcare professionals of continued reports of serious cases of hypoglycemia, or low blood sugar, and hyperglycemia, or high blood sugar, in patients taking the drug, the agency said.

The new labeling warns that diabetics shouldn't take Tequin, and includes data on other risk factors for developing low blood sugar and high blood sugar, including advanced age, kidney insufficiency, and the use of concomitant glucose-altering drugs while taking Tequin.

There have been a number of reports worldwide of life-threatening events linked to Tequin since its 1999 approval, with most problems being "reversible when properly managed, but a few had fatal outcomes," FDA noted.

Tequin is indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin, the agency said.

FDA said it would continue to monitor adverse events linked to Tequin to assure the drug's benefits outweigh its risks to patients.