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ARTICLE | Company News

Avandia gets stronger warning

November 15, 2007 2:36 AM UTC

FDA and GlaxoSmithKline (LSE:GSK; GSK) announced Wednesday an agreement to supplement the existing boxed warning for Avandia rosiglitazone to include new language noting that it has been associated with a potential increase in the risk of myocardial ischemic events such as angina or myocardial infarction. The risk was detected in a meta-analysis of short-term studies comparing Avandia to placebo, the label notes. It states that three large, long-term studies comparing Avandia to other approved oral anti-diabetic agents or placebo "have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive." The language also will be added to labels of GSK's Avandaryl rosiglitazone/glimepiride and Avandamet rosiglitazone/metformin. FDA said "there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral Type II diabetes treatments." GSK said it will conduct an FDA-requested long-term study to evaluate the potential cardiovascular risk of Avandia compared to other oral diabetes treatments. FDA said it expects that one of the comparators will be Actos pioglitazone from Takeda (Tokyo:4502) and Eli Lilly (LLY). The agency said it expects enrollment to begin around the end of November 2008, with results due in 2014.

FDA also said it will request that the labels of all approved oral anti-diabetes drugs contain language indicating that no such drug has been "conclusively shown to reduce cardiovascular risk." ...