Ongoing Safety Analysis for Avandia

Posted on April 29, 2008

UPDATE: The FDA's Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees met on July 30, 2007 to discuss the cardiovascular ischemic/thrombosis risks of thiazolidinedione drugs, with focus on rosiglitazone, as presented by FDA and GlaxoSmithKline. For more information about the meeting, see "Additional Information" link below.

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 However, other published and unpublished data from long-term clinical trials provide contradictory evidence about the risk.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.

Additional Information:

FDA MedWatch Safety Alert. Avandia (rosiglitazone). May 21, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia

FDA/Center for Drug Evaluation and Research. Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, July 30, 2007. Draft Agenda.
http://www.fda.gov/ohrms/dockets/ac/07/agenda/2007-4308a-agenda-draft.pdf

FDA/Center for Drug Evaluation and Research. Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, July 30, 2007. Briefing Information.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4308b1-00-index.htm

FDA MedWatch Safety Alert. Avandia (rosiglitazone maleate) Tablets, Actos (pioglitazone hydrochloride) Tablets, Avandaryl (rosiglitazone maleate and glimepiride) Tablets... August 14, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosi_pio