FDA Warning Points Towards Possible Avandia Lawsuit

Posted on March 17, 2008

The Food and Drug Administration (FDA) is continuing to review safety data on the drug rosiglitazone maleate. Some of these data suggest that rosiglitazone may increase a patient's risk of heart attack and heart-related deaths compared with other drugs that also treat type 2 diabetes. Rosiglitazone is sold as Avandia, Avandamet and Avandaryl.

A pooled analysis of 42 clinical studies provided by the manufacturer suggested that patients receiving short-term treatment with rosiglitazone may have a 30-40 percent greater risk of heart attack and other cardiovascular events compared with placebo or other anti-diabetic therapy. However, other published and unpublished data from long-term clinical trials provide contradictory evidence about the risk.

It is uncertain at this point whether taking rosiglitazone does increase the risk of these adverse events and if so, by how much. It is also not clear whether pioglitazone, the other approved product in the same drug class, may pose the same risk. Also, switching diabetic patients from one drug to another carries its own inherent risk. Healthcare professionals should consider these factors when deciding about treatment for their diabetic patients. FDA's review of all the available data is continuing.