In 2007, the FDA (Food and Drug Administration) took the extreme measure of issuing a safety alert, warning patients about the health risks involved in the use of the diabetic medication Avandia.
What Is An FDA Alert?
The FDA is the federal regulatory agency that oversees the safety of pharmaceuticals sold in the United States. When the FDA has concerns about a drug, it issues an alert in the form of a "black box" warning printed on the drug's label. When doctors begin reporting problematic experiences with a particular medication, the FDA will convene a hearing to determine whether or not that medication requires a black box alert. The warning gets its name from the black border drawn around the alert.
Black box warnings indicate that the drug in question has been linked to dangerous side effects. They are intended to alert physicians, pharmacists and patients to the drug's potential adverse effects. The FDA believes the drug's benefits outweigh the drug's risks, so they don't demand that the drug be taken off the market. However, black box alerts are issued for many drugs that are subsequently taken off the market.
On May 21, 2007, the FDA began requiring Avandia to carry a black box alert, warning about its potential for precipitating heart attacks and strokes.
Research indicated that while rosiglitazone, Avandia's active ingredient, was effective in the treatment of Type 2 diabetes, the drug also appeared to be associated with an increased incidence of heart disease and associated mortality. Much of this research was not new; in 1999, shortly after the FDA approved Avandia for use, the pharmaceutical company that manufactures Avandia, GlaxoSmithKline, commissioned a study, hoping to prove that Avandia had better therapeutic outcomes than Actos, an diabetic drug with a similar pharmacological mechanism, manufactured by a rival drug company. GlaxoSmithKline found, however, that while Avandia and Actos were roughly equivalent in terms of therapeutic effectiveness, Avandia patients showed a marked increase in the number of adverse cardiovascular events. GlaxoSmithKline dismissed these findings as statistically insignificant and did not report them to the FDA.
In 2007, however, a respected cardiologist named Dr. Steven E. Nissen analyzed the results of 42 clinical trials first posted on GlaxoSmithKline's website. His results, published in the New England Journal of Medicine, showed that Avandia increased the risk of heart attack in patients suffering from Type 2 diabetes by 43 percent.
Diabetes and Heart Disease
Diabetics are more prone to heart disease than members of the general population. The disease causes microscopic changes in the tissues of the heart and cardiac vessels that make them far less effective at circulating oxygen throughout the body. Almost 65 percent of Type 2 diabetics die from some sort of cardiovascular disease.
Legal options may be available to you if you or a loved one has experienced an Avandia-related heart attack or stroke. Since most states have laws that limit the time allowed to make a claim it is important that you speak with an attorney as soon as possible. Contact us to set up a free consultation with an experienced Avandia attorney today.