Changes to Avandia PI
Patients taking Avandia (rosiglitazone) and Avandamet (rosiglitazone/metformin) have been told to have their treatment reviewed following changes to key indications.
GlaxoSmithKline (GSK) announced yesterday changes to the product information for the medicines following discussions with the Therapeutic Goods Administration (TGA).
Under the new guidelines, the drugs are no longer indicated in combination with metformin and sulfonylureas as triple therapy or in combination with insulin.
The drugs are also now contraindicated in patients with NYHA (New York Heart Association) Class I and II heart failure meaning they are now contraindicated in patients with NYHA Class I to IV heart failure, and in patients with a history of cardiac failure or acute coronary syndrome.
Dr Michael Elliott, medical director of GSK Australia, said the TGA had assessed the available data and decided this was the best course of action for Australian patients.
More than 30,000 people are taking the two drugs, which were found to double the risk of cardiac failure and mortality in some people in two major studies released last year.
21-Aug-2008