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Information for Healthcare
Professionals
Gatifloxacin (marketed as Tequin)
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.
To report any unexpected adverse or serious
events associated with the use of this drug, please contact the FDA
MedWatch program using the contact information at the bottom of this
sheet.
Considerations
- Tequin is contraindicated in patients with diabetes mellitus
- In addition to diabetes, other risk factors associated with
dysglycemia while taking Tequin include older age, renal
insufficiency, and concomitant glucose-altering medications
(including but not limited to hypoglycemic medications,
corticosteroids, diuretics). Patients with these risk factors
should be closely monitored for glucose disturbances.
- Serious reports of hypoglycemia and hyperglycemia have also
occurred in patients without a history of diabetes. If signs and
symptoms of either hypoglycemia or hyperglycemia occur in any
patient being treated with Tequin, appropriate therapy must be
initiated immediately and Tequin should be discontinued.
Data Summary
In postmarketing experience worldwide, there have been reports of
disturbances in glucose homeostasis that usually occurs within 3
days of initiating Tequin therapy. Most of these events were
reversible although some resulted in fatal outcomes.
Additional Information:
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Date created: March 7, 2006 |
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