The FDA has issued an alert related to the safety of Avandia (rosiglitazone maleate), a widely used treatment for type 2 diabetes.
The agency’s action followed publication of an article in the New England Journal of Medicine (2007; Epub ahead of print) describing a meta-analysis of clinical-trial data showing increased risk of heart attack and cardiovascular-related death associated with Avandia treatment.
FDA Commissioner Andrew von Eschenbach, MD, told a congressional hearing in June that the agency would order GlaxoSmithKline, Avandia’s manufacturer, to add a “black box” warning to the drug’s labeling. For now, patients taking Avandia, especially those with underlying heart disease or who are at high risk of MI, are advised to talk to their doctor about the available treatment options.
In related news, Takeda Pharmaceuticals announced that it is working with FDA on adding a boxed warning related to risk of congestive heart failure for its type 2 diabetes medication, Actos (pioglitazone HCl).