Avandia (rosiglitazone) was approved by the FDA in 1999 for the treatment of type 2 diabetes. Avandia belongs to a group of agents know as the thiazolidinediones which are used alone or in combination with other diabetes medications as adjunct therapy to diet and exercise to improve blood glucose control in type 2 diabetes. The usual starting dose of Avandia is 4 mg daily as a single or divided dose (morning and evening). If patients do not respond to this dose after 8 to 12 weeks, it may be increased to 8 mg per day. Rosiglitazone works by lowering insulin resistance. Rosiglitazone is highly metabolized by the liver with no unchanged drug found in the urine.

On May 21, 2007, the US Food and Drug Administration (FDA) issued a safety warning related to Avandia. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other long-term clinical trials have provided contradictory evidence about the safety of Avandia. As a result, the FDA is not asking the drug’s manufacturer, GlaxoSmithKline to take any action at this time. Since the drug was approved, the FDA has been monitoring heart-related adverse events, especially fluid retention, edema, and congestive heart failure based on evidence seen in previous controlled trials and from post-marketing reports. The FDA has updated the product’s labeling on numerous occasions to reflect these data, most recently in 2006. The most recent labeling change includes a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was a result of evidence gathered from a controlled study of patients using Avandia with existing congestive heart failure.

Recently the manufacturer of Avandia has provided the FDA with evidence from short-term studies (6 months) suggesting that treatment with Avandia may result in a 30 to 40% increased risk of heart attack and other heart-related adverse events compared to patients on placebo or other diabetes therapy. This evidence hints of an increased risk of heart disease but does not prove it.

The FDA safety warning states that patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

Reference: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html.

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