Avandia: Increasing Risk of Heart Attack & Stroke? FDA Panel Says Yes

by Ralph Brindis July 14, 2010 10:17

An FDA panel just moments ago voted on whether diabetes drug Avandia increases the risk of heart attack, stroke and death. By a majority, the panel voted that there is SUFFICIENT evidence to indicate that Avandia, compared to its competitor Actos and other oral hypoglycemic drugs, does increase the risk of heart attack and stroke. However, there is INSUFFICIENT evidence that the drug causes an increased risk of death.

Today's vote is just one of nine recommendations the panel must issue, including whether the drug should remain on the market, be removed or have a stronger warning. It also will determine whether an international trial that compared Avandia and Actos should continue. (See our discussion of a Boston Globe article from late last month on the topic).

The ACC appreciates the deliberation and comments regarding Avandia from the FDA panelists today. The safety and well being of patients is of the utmost importance to the ACC and our members and the panelists today expressed reasons for concern in respect to the drug's safety.

By the panelists' comments, it is also clear more research and independent study would be helpful to fully understand and know the risks associated with this drug. Patients should speak with their physicians about all treatment options available.

What are your thoughts? Do you agree with the panel's finding?

 

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About the Authors

The ACC in Touch blog is co-authored by ACC CEO Jack Lewin, MD, current ACC President David Holmes, MD, FACC, and Board of Governors Chair Thad Waites, MD, FACC.

Jack Lewin Jack Lewin, MD, has been chief executive officer of the ACC since November 2006. Under his leadership the College has continued to build upon its standing as a national leader in advocacy, with a particular focus on reforming Medicare, Medicaid, and the financing and delivery of quality health care.

David Holmes

David Holmes, MD, FACC, became ACC president in April 2011. Dr. Holmes is the Edward W. and Betty Knight Scripps Professor in Cardiovascular Medicine at Mayo Clinic College of Medicine and an interventional cardiologist in the Division of Cardiovascular Diseases and the Department of Internal Medicine at Mayo Clinic in Rochester, Minn.

Thad Waites

Thad Waites, MD, FACC, began as Board of Governors chair in April 2011, and currently practices clinical cardiology with emphasis on interventional cardiology at Hattiesburg Clinic in Hattiesburg, Miss. He is also a board member of the Mississippi State Board of Health, and director of the cardiac cath lab at Forrest General Hospital.

Learn more about Drs. Lewin, Holmes and Waites.



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