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The New England Journal of Medicine reported on May 21, 2007 that using Avandia, a drug prescribed for diabetics, increases the risk of a heart attack by 43%. Avandia has been on the market since 1999 and is prescribed to nearly 6 million people worldwide.

The drug is prescribed for the treatment of type 2 diabetes, a leading cause of coronary heart disease, blindness, kidney failure and limb amputation that affects 200 million people – 18 million in this country alone.

Not the first warning on Avandia

This is not the first warning that consumers have received on the drug. The U.S. Food and Drug Administration (FDA) issued warnings in 2006 that the drug may be linked to heart trouble, including fluid retention, congestive heart failure and edema (the increase of fluid in an organ that causes swelling). However, the manufacturer, GlaxoSmithKline PLC, was only required to put that warning on their label.

The current FDA warning fell short of pulling Avandia off the market until further testing can be done. They noted that there is an “inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments."

Many politicians, health experts and consumer groups are firing back at the FDA for not acting soon enough and accuse the administration of putting the public at increased risk. Many consumer groups claim to have warned the FDA about the potential risks of Avandia to no avail. In addition, there have been reports that Congress will investigate why the FDA has been slow to warn the public about health risks relating to a variety drugs that have been recalled, such as Vioxx, and others where warnings were too late in being released.

Current warnings

For now, the FDA is telling patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

The drug’s website, www.avandia.com, lists the following warning:

Tell your doctor if you have heart problems or heart failure. Avandia can cause your body to keep extra fluid, which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. If you have swelling or fluid retention, shortness of breath or trouble breathing, an unusually rapid increase in weight, or unusual tiredness while taking Avandia, call your doctor right away.

If you have suffered a heart attack while using Avandia, contact an attorney whose practice focuses in this area. To contact an attorney near you, click here.