GlaxoSmithKline’s diabetes medication rosiglitazone (buy Avandia) will now carry a strong boxed warning that the drug might cause heart attacks. The company plans to design a trial to compare the drug with Takeda’s pioglitazone (Actos) to see whether the risk is unique to Avandia. Avandia and Actos already carry warnings about the risk of heart failure.
It is not clear whether Avandia drug itself raises the risk of heart attack. Studies suggesting a risk have compared Avandia with a placebo.
An analysis last spring linked Avandia tablets to a 43% higher risk of heart attacks. Patients with type-2 diabetes and underlying heart disease or who are at high risk of a heart attack should talk with their health care providers about the revise d warning.
Because no oral antidiabetes drug has been shown to reduce cardiovascular risk, the FDA is requesting that the labeling of all approved oral antidiabetes drugs describe the lack of data showing this benefit.
(Sources: FDA, Reuters, November 14, 2007.)