FDA ALERT [3/2006]
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.