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Heart Failure

GlaxoSmithKline Updates Prescribing Information for Avandia

Published in Medical Letter on the CDC and FDA, September 2nd, 2007

GlaxoSmithKline (NYSE:GSK) announced that the US Food and Drug Administration (FDA) has approved updated US prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of Type 2 diabetes. This approval allows GSK to implement changes in the label for Avandia(R) (rosiglitazone maleate) as previously committed.

The label will contain a boxed warning, which increases the prominence of an already existing warning for all medicines in the TZD class on the risk of congestive heart failure (CHF), a well known and well characterized risk in this class of medicine. The boxed warning also will note that TZDs are not recommended in patients...

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