The Food and Drug Administration (FDA) has just called for the toughest safety warning on two diabetes drugs, Avandia and Actos, whose health risks have now become a focus of Congressional concern. Avandia is manufactured by GlaxoSmith Kline and is the number one prescribed Type 2 diabetes medication in the world; Actos is manufactured by Takeda Pharmaceuticals and Eli Lilly & Company and is Avandia’s closest competitor.
FDA Commissioner, Andrew C. von Eschenbach, asked the makers of Avandia and Actos to carry the black box warning because despite the existing warnings about the cardiovascular risks associated with the drugs, they are still being prescribed to patients with significant heart failure.
A drug safety supervisor for the FDA said that she was reprimanded last year for advocating the exact same label change that Dr. von Eschenbach was now asking the drug companies to make. Avandia has been the focus of the most recent safety concerns based on the evidence that it can cause heart attacks and other serious, if not potentially-fatal, cardiovascular problems. Actos has also been seen as carrying some risk of problems, including heart failure.
Lawyers for GlaxoSmithKline said they are already getting calls from Avandia users and predict future lawsuits could run into the tens of billions of dollars; however, Glaxo Chief Executive, Jean-Pierre Garnier, has said it’s much too early to tell if Avandia will be the subject of lawsuits and is confident about the safety of Avandia.
