FDA Issues Warning On Avandia

The U.S. FDA (Food and Drug Administration) issued warnings on Avandia, a highly prescribed drug used by diabetics, on May 21, 2007. At that point the FDA only issued a warning, but is conducting further tests on the drug after several studies showed that Avandia increased user’s risks of heart attacks – a dangerous risk for those with diabetes who generally already have a higher probability of heart attacks.

The controversy began after an article was published in the New England Journal of Medicine which showed the results of many tests and concluded that those taking Avandia had a 43% greater chance of having a heart attack than those not on the drug.

The drug’s manufacturer, GlaxoSmithKline PLC (GSK), has denied allegations that the drug is unsafe. However, GSK also settled a lawsuit for $2.5 million brought by then New York Attorney General Eliot Spitzer, who accused the company of withholding information about its products from the public. In July 2010, a Food and Drug Administration advisory panel said to leave the product on the market for now, BUT that the diabetes drug poses significant safety concerns in raising the risk of heart attack.

Diabetes is a leading cause of coronary heart disease, blindness, kidney failure, and limb amputation. Type 2 diabetes is the most common form of diabetes and affects 18 million people in the United States and 200 million people worldwide. It occurs when the body cannot make enough insulin or effectively use the insulin that the body can make. Insulin assists the body to metabolize sugar for energy. Avandia was created to help the body maintain adequate blood sugar control.

Next Steps

The FDA is currently investigating the matter further. For now, it is advising users of Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, to talk to their doctors about this new information as they evaluate the available treatment options for their type 2 diabetes.

There are other forms of medication available to consumers who currently take Avandia. Check with your doctor to discuss what options are available and best for you. If you’ve suffered a heart attack while on Avandia, contact an attorney whose practice focuses in this area. To find an attorney near you, click here.