Advisory

2001-132
November 30, 2001

Important safety reminder for patients taking oral diabetes drugs of the glitazone class, Avandia® and Actos®

OTTAWA - Health Canada, following a review of current safety information and medical literature, is advising Canadians of some safety concerns related to a class of oral diabetes medications known as thiazolidinediones (TZDs) or glitazones. Two TZDs, Avandia® (rosiglitazone) and Actos® (pioglitazone), are available in Canada.

Drugs of this class can cause fluid retention that can progress to congestive heart failure. These drugs should not be used in patients with acute heart failure. If you have or have had heart failure, fluid retention or active liver disease, these safety concerns may apply to you.

Patients who develop fluid retention or swelling (edema), shortness of breath, weakness, fatigue, or excessive weight gain, should inform their physician immediately and the treatment of these patients should be reevaluated. If the symptoms are due to congestive heart failure, the medication should be discontinued. This is consistent with the safety information provided when Avandia® and Actos® were launched in Canada last year.

It should be noted that people with type 2 diabetes are at an increased risk for diabetes-related complications, such as congestive heart failure, whether they take any specific type of diabetes treatment or not.

In Canada, Actos®, in addition to diet and exercise, can be used alone to control blood sugar. Avandia® can be used alone or in combination with either metformin or sulfonylureas, in patients not controlled by diet and exercise alone.

In Canada, Actos® and Avandia® are not approved for use in combination with insulin, where these safety concerns may be more frequent.

This advisory is in addition to letters issued by the manufacturers of Actos® and Avandia®, following discussions with Health Canada, to health care professionals reminding them of the above mentioned safety concerns.

Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189

Public Inquiries:
(613) 957-2991