Avandia Diabetes Drug Linked to Heart Attacks and Congestive Heart Failure

A study recently released by the New England Journal of Medicine has linked one of the most commonly prescribed diabetes drugs, GlaxoSmithKline’s Avandia, to a significant increase in the risk of heart attack. The study reflects data involving 15,560 patients who took the drug and 12,283 patients who were given other medications or a placebo. Patients getting Avandia, known chemically as rosiglitazone, were 43 percent more likely to have a heart attack. The study strongly suggests a trend toward higher cardiac death rates in the Avandia study group.

The lead author of the study, Steven Nissen, who is the chairman of cardiology at the Cleveland Clinic in Ohio, stated that the results of this analysis raise serious concerns about the cardiovascular safety of Avandia. Furthermore, he continued, [u]nfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease.

In the wake of this study, on November 14th, it was announced that the FDA now requires Avandia’s manufacturer to include what is known as a “black box” warning on the drug’s label to warn patients of the increased risk of heart attacks. Patients who took the drug prior to this time, did not have the benefit of such a warning and, as such, may have legal claims against the drug manufacturer in the event of a cardiac event.

Avandia was first approved by the Food and Drug Administration in 1999 to treat type II diabetes. This condition, commonly called adult-onset diabetes, affects millions of people across the world. The American Diabetes Association reports that almost 21 million people in the U.S. have diabetes, a disease in which the body doesn’t properly make or use the hormone insulin to convert blood sugar to energy. Avandia acts by lowering the body’s blood sugar levels, which can cause complications - including kidney and eye damage - by increasing the body’s sensitivity to insulin. There have been tens of millions of prescriptions for Avandia written since it was approved in 1999.

Avandia has now been linked to heart failure and hypoglycemia (or extremely low blood sugar). Heart failure symptoms include:

• Chest pain
• Swelling of the extremities
• Weight fluctuations
• Difficulty breathing/Shortness of breath

Hypoglycemia symptoms include:

• Dizziness • Headaches
• Accelerated heart rate • Weakness
• Sweating • Fatigue

If you or a loved one has suffered a heart attack or congestive heart failure while taking Avandia, please contact me directly.

Claudine Q. Homolash litigates pharmaceutical injury and product liability cases across the country. Ms. Homolash heads her firm's Vioxx, Bextra and Gadolinium litigations, as well as other product liability matters.