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Two Large, Independent Outcomes Trials Offer New Important Safety Information on Cardiovascular Effects of AVANDIA(R)
Date:6/9/2008

l in patients with type 2 diabetes.

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. Taking AVANDIA with insulin or with nitrates is not recommended.

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

Review your medical history and tell your doctor if you:

-- Have heart failure or other heart problems

-- Have liver problems or liver disease

-- Are pregnant or are nursing

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy.

More fractures have been observed in women taking AVANDIA.

For more information about AVANDIA, please see Patient Information. For further information on AVANDIA, please see full Prescribing Information.

Media Contacts: Bernadette King Doug Hochstedler

(215) 751-7709 (646) 244-6600


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SOURCE GlaxoSmithKline
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