New Prescribing Information For Avandia (Rosiglitazone)
It is generally known that in America more than 4.5 million people suffer from the most common complications of type 2 diabetes – congestive heart failure (CHF).
CHF can be described as a condition when the heart cannot pump enough blood to the body’s other organs. In many cases it leads to fluid retention, or edema.
Avandia (Rosiglitazone) is referred to the thiazolidinediones (TZD) class of medicines used in the treatment of Type 2 diabetes. Avandia drug was first approved by the US Food and Drug Administration in 1999. And since 2001, US prescribing information for generic Avandia has included a warning for “Cardiac Failure and Other Cardiac Effects”. At the same time it was advised to  discontinue taking Avandia medication if patients’ cardiac status worsened
Today GlaxoSmithKline (NYSE: GSK) reported that the US Food and Drug Administration (FDA) has approved updated US prescribing information for Rosiglitazone diabetes. This approval allows GSK to fulfill changes in the label for Rosiglitazone generic as previously committed. Generally these changes related to CHF are being implemented on the labels of all rosiglitazone-containing products such as Avandia, Avandaryl (rosiglitazone maleate and glimepiride) and Avandamet (rosiglitazone maleate and metformin hydrochloride).
According to the announcement, the label will include a boxed warning, suggesting that medicines of TZD class 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. However, the change in CHF labeling is not related to the FDA’s review of additional data on the risk of myocardial ischemic events, which include heart attack.
