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GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition
Date:10/30/2008

otal mortality for AVANDIA compared to other commonly used oral diabetes medicines on the market. The current FDA-approved label for AVANDIA states that the available data are inconclusive on the risk of myocardial ischemia.

Important Safety Information about AVANDIA(R) (rosiglitazone maleate)

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes. Taking AVANDIA with insulin or nitrates is not recommended.

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDIA tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

Before taking AVANDIA, review your medical history and tell your doctor if you:

-- Have heart failure or other heart problems, or are on any medicines for

high blood pressure, high cholesterol or heart failure, or for

prevention of heart disease or stroke.

-- Take insulin or nitrate medicines.

-- Have a type of diabetic eye disease called macular edema.

-- Have liver problems or had liver problems while taking REZULIN(R)

(troglitazone).

-- Are pregnant or planning to become preg
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SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

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