For the Public - Update regarding the association of Tequin (gatifloxacin) with serious hypoglycemia and hyperglycemia

Starting date:

May 12, 2006

Posting date:

May 17, 2006

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000476

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Bristol-Myers Squibb Canada.

Contact the company for a copy of any references, attachments or enclosures.

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(PDF Version - 81 K)

Contact : MHPD

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on Tequin* (gatifloxacin)

12 May 2006

Subject: Updated safety information for TEQUIN*(gatifloxacin) and serious hypoglycemia and hyperglycemia

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

Please be aware of the following important safety information that may be relevant to patients receiving TEQUIN. The Product Monograph for TEQUIN has been updated to reflect this new safety information. Bristol-Myers Squibb Canada has also issued a letter to health professionals advising them of this new safety information.

• TEQUIN should not be used in patients with diabetes mellitus
• 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. However both low and, in particular, high blood sugar levels occurred in some patients with no known history of diabetes. Patients over 65 years of age with additional medical problems or taking additional medications may be at risk for high and/or low blood sugar.
• All patients prescribed TEQUIN should discuss how to detect changes in their blood sugar with their healthcare provider and the steps that should be taken if they detect such changes.
• Patients should discuss taking TEQUIN with their healthcare provider if they have kidney problems (as an adjustment of dose may be needed), are taking any other medication or are 65 years of age or older.

For more information about the revisions to the prescribing information for TEQUIN, patients should consult their healthcare professional. Patients should not discontinue their medication without consulting their physician first.

The full copy of the Product Monograph can be found at: www.bmscanada.ca

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

Email: MHPD_DPSC@hc-sc.gc.ca

Tel.: (613) 954-6522

Fax.: (613) 952-7738

original signed by

Dan Chiche, MD

Vice-President, Scientific Affairs

* TM of Bristol-Myers Squibb Company used under licence by Bristol-Myers Squibb Canada