Breaking News: Use of Avandia Restricted

by Jack Lewin September 23, 2010 06:12

The bad news for Avandia continues. The FDA announced today that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control the disease with Actos (pioglitazone) or other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia. This is an interesting announcement given that Actos is currently under review for a potential link to bladder cancer (no definitive link has been made as of yet).

In July, after an intensive two-day hearing regarding the conflicting data surrounding Avandia, a FDA advisory panel voted in late July to keep the drug on the market with the addition of warnings and stricter product labeling. See previous blog coverage of Avandia for more background.

UPDATE: European regulators have announced that Avandia's approval will be withdrawn.

 

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About the Authors

The ACC in Touch blog is co-authored by current ACC President William Zoghbi, MD, FACC, and Board of Governors Chair Dipti Itchhaporia, MD, FACC.  William Zoghbi

William Zoghbi, MD, FACC, became ACC president in March 2012. Dr. Zoghbi is the William L. Winters endowed Chair of Cardiovascular Imaging at The Methodist DeBakey Heart & Vascular Center and director of the Cardiovascular Imaging Institute at the Methodist Hospital in Houston, Texas.
Dipti Itchhaporia

Dipti Itchhaporia, MD, FACC, began as the chair of the Board of Governors in March 2012. Dr. Itchhaporia holds the Robert and Georgia Roth Chair for Excellence in Cardiac Care and is the medical director of disease management for Hoag Heart and Vascular Institute.

Learn more about Drs. Zoghbi and Itchhaporia.

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