In the findings of a study that will appear in the June 14 issue of the New England Journal of Medicine, researchers found that the risk of a heart attack was increased 43 percent among those taking Avandia. There was also a 64 percent increased risk of dying from cardiovascular causes while taking Avandia.

The Avandia discoveries were considered enough of a public health matter that the New England Journal of Medicine to release the findings several weeks before they appeared in print.
Almost 21 million people in the U.S. have diabetes, a disease in which the body doesn’t property make or use the hormone insulin to convert blood sugar to energy, according to the American Diabetes Association.

Avandia is a medication used by individual with diabetes to control blood sugar. Almost 21 million people in the U.S. have diabetes. Diabetes is a disease in which the body does not property produce or use the hormone insulin to convert blood sugar to energy. About 7 million people worldwide have taken Avandia and about 1 million people American currently use Avandia (according to Glaxo). Hundreds of people who had heart problems, were prescribed Avandia without knowing about the risks.

There is evidence that Glaxo was aware of the increased risk of heart problems as early as 2000, but failed to notify the public. Glaxo was warned by the U.S. regulators in 2001 against down playing the risk of cardiac disease associated with Avandia and an increased risk of heart attacks.

A year earlier, in March 2000, a diabetes expert from the University of North Carolina, Chapel Hill, wrote a letter to the Food and Drug Administration complaining about the company’s “rampant abuse of clinical trial data” related to the drug’s cardiovascular safety. Two letters found on the agency’s website, along with the concerns voiced by its own advisers before the drug reached pharmacy shelves, are providing evidence of concern about Avandia’s impact on the heart. A Cleveland Clinic study released this week found Avandia users were 43 percent more likely to have a heart attach than those given other drugs.

In July 2001, the FDA warned Glaxo in a letter that its marketers should stop denying or minimizing that patients taking the drug with insulin had an increased risk of “heart failure or other cardiovascular adverse events,” according to a copy on the FDA’s website. Regulators criticized Glaxo for continuing to “engage in false or misleading promotion of Avandia.”

The FDA sent five warning letters to Glaxo in a two year period staring in 1999 over the company’s advertising and marketing of the diabetes drug (Avandia).

A panel of outside FDA advisors voted unanimously on April 22, 1999, that Avandia effectively controlled blood sugar in type 2 diabetics and agreed that drug’s safety outweighed it risk. Some called for warning and more studies on heart and liver risks.

In February 2001, the company agreed to change Avandia’s warning label to show that studies found an increased risk of heart problems for patients taking the drug in combination with insulin. Company officials who know the risks “denied their existence” at a meeting of the American Association of Clinical Endocrinologist, FDA officials noted in the July 2001 letter.

Congressional investigators are examining whether the FDA handled the oversight of Avandia properly and have scheduled hearings for June.


The US Senate has already begun an investigation into Glaxo and the FDA regarding this potential health care fiasco.
The most common related problems with Avandia are:

• Heart attack
• Stroke
• Liver problems
• Other heart problems

If you or a member of your family has any of these conditions above and has taken Avandia, then you may qualify for a potential lawsuit claim.

If you have any questions about the information provided above, please contact us.

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