July 2007 Issues

FDA Asking Advisers if Avandia Should Stay on the Market

Summary: On Monday, July 30, 2007, the FDA will ask a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee whether GlaxoSmithKline’s diabetes drug, Avandia (rosiglitazone), should remain on the market. ♦ The agency is concerned that the drug, used by millions of people worldwide, can cause heart attacks or other cardiovascular problems. ♦ According to the FDA, the safety concerns with Avandia also apply to GSK’s combination products, Avandamet (rosiglitazone + metformin) and Avandryl (rosiglitazone + glimepride).

European Renal Association - European Dialysis and Transplant Association (ERA-EDTA)

Summary: The cardiac safety of erythropoiesis-stimulating agents (ESAs) was not a major topic or concern at the major nephrology meeting in Europe, ERA-EDTA. ♦ Eleven European nephrologists were interviewed, and many do not believe that ESAs are cardiotoxic, at least not the way they use them in Europe, which is more conservatively than some American doctors. ♦ If there is a problem, it’s an American problem, European nephrologists said. ♦ They said their use of ESAs has not changed, and they do not expect European guidelines or labels to be revised.