The FDA has issued a safety warning relating to the drug rosiglitazone maleate, marketed under the brand name Avandia. Safety data pooled from controlled clinical trials shows a significant increase in the risk of heart attack and heart related deaths in patients that use the drug Avandia, to help control type-2 diabetes.
Other published data from long-term clinical trials of Avandia provide contradictory evidence regarding the risk of heart problems in patients taking Avandia. The Food and Drug Administration’s (FDA) review of all available data is still ongoing.
The FDA has not yet confirmed any clinical significance of the reported increased risk of heart related problems in the context of other studies. Myocardial ischemic events are described in the warning section of the rosiglitzsone label.
The FDA is unsure whether other approved medications in the same class or other drugs used for treating type-2 diabetes have less, the same or greater health risks. The FDA is providing this information to prescribers so they and their patients can make informed treatment decisions.
This information reflects FDA’s current analysis of available data concerning this drug. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging drug safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing the product. FDA is considering, but has not reached a conclusion about, whether this information warrants any regulatory action.