Health Canada Endorsed Important Safety Information on

Tequin* (gatifloxacin)

December 19, 2005

Subject: Association of the antibiotic TEQUIN* (gatifloxacin) with potentially serious high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia)

Bristol-Myers Squibb Canada, in collaboration with Health Canada, is informing healthcare professionals of important safety information regarding TEQUIN* (gatifloxacin). TEQUIN is an antibiotic used to treat certain lung, sinus, or urinary tract infections, and also to treat certain sexually transmitted diseases.

Please be aware of the following important safety information that may be relevant to patients receiving TEQUIN.

Cases of both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), that can sometimes be serious and life-threatening, have been reported in patients treated with TEQUIN. Low and high blood sugar can be reversible if recognized and treated.

Some, but not all, of these cases have been reported with TEQUIN in diabetic patients. Patients over 75 years of age with additional medical problems or taking additional medications may be at risk for high and/or low blood sugar.

Diabetics are at a higher risk of developing low blood sugar. However both low and, in particular, high blood sugar levels occurred in some patients with no known history of diabetes.

Patients who develop signs and symptoms of low or high blood sugar, as described by their physician, while on TEQUIN should stop taking TEQUIN and contact their healthcare professional at once.

Bristol-Myers Squibb Canada wants to remind physicians and their patients that disturbances of blood sugar, including symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), have been reported with TEQUIN, particularly in diabetic patients. Patients over 75 years of age with additional medical problems or taking additional medications may be at higher risk for high or low blood sugar. All patients taking TEQUIN, particularly those with diabetes or who suspect they may have diabetes, should discuss how to detect changes in their blood sugar with their healthcare professional.

Bristol-Myers Squibb Canada is committed to the delivery of quality pharmaceutical products and to ensuring the communication of safety information that is important to patients and health care professionals.

If you have questions about your current prescription, please contact your physician or pharmacist.

For media inquiries, please contact Mr. Marc Osborne, Bristol-Myers Squibb, (514) 333-2463.

The safety of patients is a priority for Bristol-Myers Squibb Canada Inc. Information about adverse drug reactions is gathered by both Bristol-Myers Squibb Canada and Health Canada, via its Canadian Adverse Drug Reaction Monitoring Program (CADRMP). Any suspected adverse drug reactions in patients receiving TEQUIN can be reported to:

Bristol-Myers Squibb Canada

2365 Côte-de-Liesse

Montréal, Québec

H4N 2M7

Tel : 866-463-6267

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: mhpd_dpsc@hc-sc.gc.ca

Tel: (613) 954-6522

Fax: (613) 952-7738

original signed by

Dan Chiche, MD

Vice-President, Scientific Affairs