11/14/2007- GlaxoSmithKline said Wednesday it is implementing changes to the U.S. product label for Avandia, based on a Food and Drug Administration review of myocardial ischemia data on the diabetes drug.

Glaxo said Avandia's 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, Glaxo said.

The Avandia label also has been revised to add that Avandia is not recommended -- though not contraindicated -- for use with patients who are taking insulin or nitrates.

In addition, 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.