OTTAWA — Health Canada has announced new restrictions and a consent form for the diabetes medication rosiglitazone, sold under the brand name Avandia, because of an increased risk of heart-related illness.
The national drug regulator said Thursday that it changed the restrictions after reviewing recent data and in conjunction with manufacturer GlaxoSmithKline Inc.
The drug may increase the risk of serious heart problems, including heart failure, angina (chest pain), heart attack or fluid retention (with or without rapid weight gain).
The drug should not be used by patients who have or have had heart problems, the agency said in a release recently.
Health Canada says the medication should be used only in patients with Type 2 diabetes when all other diabetes medicines taken orally have not lowered blood sugar enough, or are not appropriate.
The agency said that patients should not stop taking the medication until they have seen their physician to discuss their diabetes treatment, including other options and the benefits and risks of taking rosiglitazone.
Before starting or renewing a prescription for Avandia, doctors must now advise patients to read the consumer information for the drug and to read and sign a consent form indicating they understand the heart-related risks of the medication and they have discussed other treatment options.
The restrictions affect Avandia (rosiglitazone), Avandamet (contains both rosiglitazone and metformin) and Avandaryl (contains both rosiglitazone and glimepiride).