The panel also recommended that Avandia, also known as rosiglitazone, should be studied further and should carry a "black-box" warning. Some experts also suggested the label caution against using the drug together with insulin, because current studies suggest that doing so may elevate heart risks. Nonetheless, the joint use of Avandia and insulin is currently FDA-approved.
Welcoming the FDA's decision, Avandia manufacturer GlaxoSmithKline said it will continue to provide information to the FDA to assist in the agency's final decision-making.
Earlier the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted that the data suggests some ischemic risk with Avandia.
According to AP reports, Glaxo maintains that there is no increased risk with the drug, citing its own analysis of studies of Avandia. About 1 million Americans with Type-2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin.
"Diabetes is a progressive disease that exacts a terrible toll on its victims, and it is important that Avandia remain a treatment option for patients," Dr. Ronald Krall, Chief Medical Officer at GlaxoSmithKline explained.


