The U.S. Food and Drug Administration announced today that it will significantly restrict the use of Avandia (rosiglitazone), but will allow the controversial diabetes drug to remain on the market. The FDA will permit doctors to only prescribe Avandia to patients with Type 2 diabetes who cannot control the chronic disease with alternate medications. Heavy controversy has surrounded GlaxoSmithKline’s diabetes drug since data from numerous studies suggested that patients taking Avandia are at risk of suffering heart attacks and strokes, among other life-threatening cardiovascular events. “The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said DA commissioner Margaret A. Hamburg, M.D.
Also this year the European Medicines Agency reviewed the safety of Avandia and on September 23 recommended the suspension of the diabetes drug, stating that Avandia “will stop being available in Europe within the next few months.”