November, 1st , 2007, Health Canada, the Canadian equivalent to the Saudi Food and Drug Authority (SFDA), announced new restrictions on the use of Rosiglitazone containing products due to cardiac safety concerns (Avandia, Avandamet, Avandaryl)

Rosiglitazone-containing products are used in the treatment of type 2 diabetes mellitus.

Further to a Health Canada assessment of adverse event reports, published articles* and other available information on congestive heart failure, myocardial infarction, and related events, the Product Monographs for rosiglitazone-containing products are being updated and will include the following new usage restrictions:

• Rosiglitazone (AVANDIA®) is no longer approved as monotherapy for type 2 diabetes, except when metformin use is contraindicated or not tolerated.
• Rosiglitazone is no longer approved for use in combination with a sulfonylurea, except when metformin is contraindicated or not tolerated.
•  Treatment with all rosiglitazone products is now contraindicated in patients with any stage of heart failure.
  

   

Also, as a reminder:

•   Rosiglitazone is not indicated for use with insulin. This combination is associated with an increased risk of heart failure.
•   Rosiglitazone is not indicated for triple therapy (i.e., therapy with rosiglitazone in combination with both metformin and a sulfonylurea). Increases in congestive heart failure and other fluid retention-related events have been reported in patients receiving rosiglitazone as part of triple therapy.

Dual therapy

When adequate glycemic control is not obtained through diet and exercise plus monotherapy, then rosiglitazone can be used in dual therapy, as follows:

• use in combination with metformin; or
• when metformin is contraindicated or not tolerated, use in combination with a sulfonylurea
• Rosiglitazone can be added to (not substituted for) the monotherapy agent.

Patients are being advised to talk to their doctors about the risks of continuing rosiglitazone therapy if they have underlying heart disease, or are at high risk of heart attack or heart failure

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug

reactions the National Pharmacovigilance Center on the Internet at