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FDA approves updated US prescribing information for Avandia and Actos

The FDA has approved updated US prescribing information for the thiazolidinediones class of medicines used in the treatment of type 2 diabetes, which include Avandia and Actos

The FDA has approved updated US prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of type 2 diabetes, which include GlaxoSmithKline's Avandia (roseglitazone) and Takeda's Actos (pioglitazone). 

The approval thus allows GSK and Takeda to implement changes in the label for the drugs concerned. The new 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).

The boxed warning states that TZDs are not recommended in patients with symptomatic heart failure and that initiation of TZDs in patients with established NYHA Class III or IV heart failure is contraindicated. The side-effect profile has also been updated regarding initiation of Avandia in patients with NYHA Class III or IV heart failure.

Information about CHF has been included in the prescribing information for Avandia since 1999, when the medicine was first approved by the FDA. 

Since 2001, US prescribing information for Avandia has included a warning for "Cardiac Failure and Other Cardiac Effects" with a recommendation that use of Avandia be discontinued in patients if their cardiac health becomes worse.

The changes related to CHF are being implemented on the labels of all rosiglitazone/ pioiglitazone-containing products, including Avandia, Avandamet (rosiglitazone and metformin), Avandaryl (rosiglitazone and glimepiride), as well as Actos and its other formulations.

15th August 2007

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