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GSK Revises US Labeling for Avandia(R)
Date:11/14/2007

LONDON and PHILADELPHIA, Nov. 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that it is implementing changes to the US product label for Avandia(R) (rosiglitazone maleate), based on an extensive and thorough review by the FDA of myocardial ischemia data on Avandia, the most widely studied oral anti-diabetic medicine available.

The existing boxed warning has been revised to add the FDA's conclusion that, while an FDA meta-analysis of short-term studies -- mostly against placebo -- showed an association between Avandia and an increase in myocardial ischemic events, that risk was not confirmed or excluded in three long-term clinical trials comparing Avandia against both placebo and other oral anti- diabetes medicines. The box will state that the available data on the risk of myocardial ischemia are inconclusive.

The FDA has also concluded there is insufficient information available to determine whether any oral anti-diabetic medicine reduces cardiovascular risk. The FDA has directed that the sentence -- "There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Avandia or any other oral antidiabetic drugs" -- will be added as a warning on the labels of all oral anti-diabetic medicines.

The Avandia label also has been updated to add that Avandia is not recommended -- though not contraindicated -- for use with patients who are taking insulin or nitrates. The label summarizes the data on myocardial ischemia to help doctors continue to evaluate which patients could benefit from taking Avandia, and those for whom alternative treatment should be considered.

The changes are now included in labeling for Avandia, and will be incorporated into future revised labeling for all approved rosiglitazone-containing products, including Avandamet (rosiglitazone maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate and glimepiride). GSK is also preparing a Medication Guide to
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SOURCE GlaxoSmithKline
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