On February 15, 2006, Bristol Myers Squibb (BMS) issued a Dear Healthcare Professional (DHCP) letter to U.S. physicians announcing an update to the U.S. labeling for Tequin (gatifloxacin) Tablets and Injection. The update includes labeling changes to strengthen the existing WARNING on hypoglycemia and hyperglycemia and adds a CONTRAINDICATION for use in diabetic patients. Serious reports of hypoglycemia and hyperglycemia continue to occur in patients both with and without a history of diabetes. These events can occur throughout the course of Tequin therapy. The labeling has also been updated to identify other risk factors for developing hypoglycemia and hyperglycemia, (i.e., older age, abnormal kidney function, and other blood glucose altering medications being used at the same time) while taking Tequin (gatifloxacin), and includes a recommendation for close medical monitoring.

FDA will review all available data and determine whether additional changes to labeling, or other regulatory actions, are warranted.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.