New York Times, "FDA Issues Strictest Warning on Diabetes Drugs Avandia and Actos"

          The Food and Drug Administration has called for the toughest safety warning on two diabetes drugs, Avandia and Actos, whose health risks have become a focus of Congressional concern. That decision, disclosed on Wednesday by the FDA commissioner at a packed House hearing, comes more than a year after the agency's safety reviewers strongly recommended just such a step. And it occurs amid a Congressional investigation into why the agency delayed its warnings about Avandia for years.
          In a written statement, the commissioner, Andrew C. von Eschenbach, said the agency has asked the makers of Actos and Avandia to carry the more prominent warning, a so-called black box warning, of its heart risks because "despite existing warnings, these drugs were being prescribed to patients with significant heart failure." The statement said the agency requested the label changes on May 23, which was two days after a medical journal article and editorial about Avandia’s potential heart risks set off the current controversy. Word of the label changes, however, had not been made public before Wednesday’s hearing.
          Dr. Rosemary Johann-Liang, a drug safety supervisor for the agency, had said in an interview this week that she was reprimanded last year for advocating the very label change that Dr. von Eschenbach said the agency was now asking the drug companies to make. Avandia, a Type 2 diabetes treatment made by GlaxoSmithKline, has been the focus of most of the recent safety concerns, based on evidence that it can potentially cause heart attacks or other cardiovascular problems. But its closest competitor, Actos, a drug from Takeda Pharmaceuticals and Eli Lilly & Company, has also been seen as carrying some risk of problems, including heart failure.