by Ann Marie Dwyer

Created on: March 24, 2009   Last Updated: September 16, 2011

Avandia is not the drug the Food and Drug Administration (FDA) originally thought it was. Studies are revealing worldwide GlaxoSmithKline's (GSK) Avandia is a significant risk to patients.

1. What is Avandia, and why is it prescribed?

Avandia is the brand name of the drug rosiglitazone. It is used with diet and exercise to reduce blood sugar in type 2 diabetes patients, those who are non-insulin dependent, by sensitizing the body to better use its own insulin.

Avandia was approved by the FDA in 1999. By 2006, 13.2 million people were taking Avandia, and at least four million were still taking the drug in 2008. Avandia's patent expires in 2009.

2. What has changed since 1999?

In 2001, Dr. John B. Buse wrote a letter to the FDA regarding the increased risk of heart attack in Avandia patients. Dr. Buse went on to study Avandia's effects and review information GSK presented to the FDA prior to its approval.

The FDA ordered GSK to provide package and label warnings about the risks. GSK was slow to respond and was ordered to provide the warnings again.

The FDA sent undercover investigators to a pharmaceutical conference where GSK had not sufficiently posted warnings on materials promoting Avandia. In May 2001, the FDA ordered GSK to write letters to doctors prescribing Avandia warning them of the risks.

Long term studies and reevaluation of initial studies of Avandia, released in 2007, show patients using the drug have a 30-40 per cent higher risk of heart attack (myocardial infarction) and heart events, such as fluid retention, swelling and congestive heart failure.

By 2008, doctors and patients had reported to the FDA 14 cases of liver failure. Twelve resulted in death.

3. Why did the FDA issue an alert in 2007?

Based on the findings of the studies reported in 2007, the FDA issued an alert for all physicians to reassess patients taking Avandia in light of the increased risk of heart-related events.

The FDA chose not to recall the drug when it issued the alert because there is inherent risk for patients who change medications for diabetes even with no other specific risk factors.

GSK was ordered to continue providing labels bearing the warning of the increased heart risk while the FDA investigates additional study data to determine if the heart-related events and deaths of Avandia patients were due to taking the drug.

4. Are there other risks?

Public Citizen, the Health Research Group (HRG) filed a petition with the FDA to recall Avandia based on twelve fatal cases

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