| Avandia
In the findings of a study in the New England Journal of Medicine, Dr. Steven Nissen and his colleague Kathy Wolski, evaluated 42 studies that compared patients taking Avandia with patients not using the drug. The studies included nearly 28,000 patients, 15,560 of whom were taking Avandia.
The researchers found the risk of a heart attack was increased 43 percent among those taking Avandia. There is also a 64 percent increased risk of dying from cardiovascular causes while taking the drug.
The implications of these discoveries were considered enough of a public health matter to have caused the New England Journal of Medicine to release the findings several weeks before they appeared in print.
What is Avandia?
Avandia is the brand name for an anti-diabetic drug marketed by GlaxoSmithKline. It was approved by the FDA in 1999 and millions of Americans with diabetes take the drug to help control their blood sugar levels.
How does Avandia work?
It contains rosiglitazone, which is part of the class of prescription drugs called called thiazolidinediones (TZDs). It helps the body use the insulin that it already manufactures. Avandia makes it possible for the insulin the body produces to move glucose out of the bloodstream and into the cells where it's needed for energy.
Why are these findings considered a public health matter?
Currently, 1 million Americans take Avandia for the treatment of Type 2 diabetes. In this form of the disease, the patient exhibits high levels of sugar in the blood because the body does not respond to insulin, a hormone released by the pancreas that helps glucose move into the cells where it can be used for energy.
How significant is Avandia's increased risk of heart attack?
More than 6 million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack.
There were 86 heart attacks and 39 deaths among the 15,560 Avandia patients, compared with 72 heart attacks and 22 deaths among the 12,283 patients not taking Avandia.
Nissen and Wolski concluded from this data that Avandia may be capable of provoking heart attacks or death from cardiovascular causes after relatively short-term exposure in patients who are already susceptible to these conditions.
What is the FDA's response to these findings?
The Food and Drug Administration urged diabetics taking Avandia to talk to their doctors about whether they should remain on the treatment. However, the agency didn't issue a call for a sharper warning label on the drug.
Irwin & Boesen represents persons who have been injured by
using Avandia.
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trial experience, as one of Colorado's leading law firms, to provide
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