As a result of serious concerns about the side effects of Avandia, which include an increased risk of heart attacks, congestive heart failure and other serious injuries, the American Diabetes Association and the European Association for the Study of Diabetes have dropped the drug from their consensus statement on type 2 diabetes treatments, unanimously advising against use of the drug.
Statements were published online in Diabetes Care and Diabetologia, updating the groups’ recommendations for treating type 2 diabetes.
They indicate that first line therapy should start with lifestyle interventions and metformin therapy, with other agents added as necessary to achieve long-term glycemic control.
Avandia (rosiglitazone), is a type 2 diabetes drug manufactured by GlaxoSmithKline PLC, which was approved by the FDA in 1999. It is part of a class of medications known as thiazolidinedione agents, which increase the body’s sensitivity to insulin and aid in the management of blood sugar in diabetics.
Although the associations unanimously advised against using Avandia, they indicated that another thiazolidinedion agent, Actos (pioglitazone), is the most appropriate second-line therapy, along with basal insulin or a sulfonylurea drug. GLP-1 agents were also suggested for second-line diabetes therapy when there is no hypoglycemia.
Third-line therapy involves intensive insulin with metformin and lifestyle interventions.
The decision to bump Avandia off the consensus statement on type 2 diabetes treatments was prompted by a growing amount of clinical data and experiences surrounding the drug. Studies have demonstrated that the Avandia could increase the risk of heart attacks by 43%, and the FDA has added “black box” warnings to the drug about the risk of heart attacks and congestive heart failure.
A number of doctors have already made the decision on their own to remove their patients from Avandia, and GlaxoSmithKline continues to feel the effects of the downfall of their once hot drug. According to the drug maker’s third quarter earnings statement released Wednesday, profit fell 22% in the quarter, largely based on continued slowing for sales of Avandia surrounding the heart concerns.
The announcement by the American Diabetes Association and European Association for the Study of Diabetes is likely to further damage Glaxo’s Avandia sales.
Glaxo also faces a growing number of Avandia lawsuits filed by users who have suffered heart attacks, congestive heart failure, strokes, bone fractures, death and a sudden vision problem, known as macular edema. All federal Avandia litigation has been centralized in the Eastern District of Pennsylvania through a coordinated multidistrict litigation (MDL).