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Greg Monforton and Partners

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Windsor, Ontario N9A 6T3

519-258-6490
800-663-1145

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June 6, 2007—The FDA announced it is calling for a black box warning on Avandia based on data that the diabetes drug is associated with an elevated risk of cardiovascular problems. A black box warning is the toughest safety warning available to the FDA.

The safety agency at the FDA had been calling for such a warning for more than a year, but the FDA previously refused their recommendations. The label changes finally were requested by the FDA on May 23, 2007, two days after the New England Journal of Medicine published an article about the potential heart risks.

More than one million prescriptions for Avandia were filled in Canada in 2006, ranking it the third most popular oral diabetes drug.

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May 22, 2007—The New England Journal of Medicine reported that Avandia may be associated with a significant increase in the risk of heart attacks and other cardiovascular problems.

Dr. Steven Nissen, a cardiologist with the Cleveland Clinic, reviewed more than 40 clinical studies involving Avandia. Based on his review, Dr. Nissen concluded that Avandia raises the risk of heart attack by 43 percent. He estimates that tens of thousands of deaths are attributed to Avandia.

GlaxoSmithKline has known of the cardiovascular risks of Avandia for an extended period of time. In August 2006, the company conducted a similar analysis of clinical trials and estimated the heart risk increased by 31 percent among Avandia patients.

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Avandia was approved for sale in 1999 for treatment of Type 2 diabetes. It is sold alone as Avandia and in combination with other drugs, including Avandamet and Avandryl.

Cardiologists have noted that alternative treatments with more favorable risk profiles exist, and have questioned why doctors would continue to prescribe Avandia given these risks. Patients taking Avandia are encouraged not to stop taking Avandia without first consulting with their physicians.

Concerns about the safety of Avandia date back to March 2000, when Dr. John Buse, president-elected of the American Diabetes Association and faculty member at the University of North Carolina in Chapel Hill, sent a letter to the FDA and cited "a worrisome trend in cardiovascular deaths and severe adverse events" among patients using Avandia.

Greg Monforton and Partners has grown to a highly respected products liability law firm with offices conveniently located throughout Windsor and Essex County, together with affiliate relationships with law firms throughout Ontario, Canada and the United States.

We are committed to protecting the rights of individuals injured by dangerous pharmaceuticals. The firm never represents insurance companies or product manufacturers. We only help people.

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Greg Monforton and Partners is investigating legal claims against GlaxoSmithKline on behalf of Canadians injured by Avandia.

If you or a loved one has suffered a heart attack or other serious cardiovascular event following of Avandia, we encourage you to contact us. We will represent clients throughout Canada in lawsuits against GlaxoSmithKline.

For more information about Avandia, please complete our online form.

FDA Issues Strictest Warning on Diabetes Drugs
The New York Times
June 7, 2007

Glaxo in a Soup Over Avandia
Reuters
May 25, 2007

Heart Risk Seen in Avandia
The New York Times
May 22, 2007