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Bristol Myers Squibb Proposes Changes to Tequin Label

Date: 2/22/2006
Reason: Warning of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and a contraindication for use in diabetic patients.
Distribution: Nationwide.

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Bristol Myers Squibb notified the FDA and healthcare professionals about proposed changes to the prescribing information for Tequin, (gatifloxacin) including an updating of the existing warning on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and a contraindication for use in diabetic patients. The changes also include 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. 

Specific wording of these additions and revisions to the labeling is pending FDA review and approval.

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