WASHINGTON, D.C. – Senator Tom Harkin (D-IA), Chairman of the Health, Education, Labor and Pensions (HELP) Committee, released the following statement regarding a review by the U.S. Food and Drug Administration (FDA) of potential risks associated with the drug AVANDIA (rosiglitazone maleate), which is a medication manufactured by GlaxoSmithKline to treat type 2 diabetes mellitus.
FDA is evaluating data, submitted in August 2009, from a large, long-term clinical study called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD), which was designed to evaluate the cardiovascular safety of rosiglitazone. As part of its evaluation, FDA re-convened a Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee to review and advise the agency on the totality of new and existing cardiovascular safety data on AVANDIA. Today, the Committee voted to keep the drug on the market with heightened warnings about its safety.
“AVANDIA is a widely used drug, and it is imperative that the risks associated with its use be properly understood and vetted,” said Harkin. “I urge FDA to carefully consider today’s deliberations by the Joint Advisory Committee, and to make a final decision on how best to protect consumers as soon as possible. The safety of those suffering with diabetes must be our primary concern.”
AVANDIA was originally approved for use by FDA in May 1999. In 2007, a cardiologist at the Cleveland Clinic, Dr. Steven E. Nissen, published a study that suggested the medications carried cardiovascular risks. Following that study, FDA left AVANDIA on the market, as recommended by its expert advisory committee, but directed GlaxoSmithKline to modify AVANDIA’s label to include a caution regarding heart attack risk.