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From: GlaxoSmithKline

August 2007

Important Prescribing Information

GlaxoSmithKline (GSK) is fully committed to the timely communication of safety information about its products to the healthcare community. In collaboration with the U.S. Food and Drug Administration, we are updating the rosiglitazone prescribing information with regard to heart failure.  This labeling affects rosiglitazone-containing products, i.e. Avandia® (rosiglitazone maleate) tablets, Avandamet (rosiglitazone maleate and metformin hydrocloride) tablets, and Avandaryl (rosiglitazone maleate and glimeperide) Tablets, which are used in treating type 2 diabetes melitus.

Important changes to the Prescribing Information for Avandia, Avandamet and Avandaryl include:

1. Boxed warning regarding heart failure...

2. Contraindication for initiation of rosiglitazone in patients with NYHA class III and IV heart failure.


. Thiazolidinediones, including rosiglitazone, cuase or exacerbate congestive heart failure in some patients. After initiation of Avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and / or edema).  If these symptoms develop, the heart failure should be managed according to current standards of care.  Futhermore, discontinuation or dose reduction of AVANDIA must be considered.

. AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with establised NYHA Class III or Class  IV heart failure is contraindicated.


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