Myocardial infarction (MI or AMI for acute myocardial infarction), commonly known as a heart attack, occurs when the blood supply to part of the heart is interrupted causing some heart cells to die. The resulting ischemia (restriction in blood supply) and oxygen shortage, if left untreated for a sufficient period, can cause damage and/or death (infarction) of heart muscle tissue (myocardium).

Heart attacks are the leading cause of death for both men and women all over the world.

FDA approved Avandia for market in 1999. The FDA approved the use of Avandia to control blood sugar levels in type 2 diabetes in 1999. About one million Americans take Avandia today. At the time the FDA approved the drug, the agency’s primary medical reviewer expressed concerns about a potential “deleterious long-term effect on the heart” and recommended a post-marketing study to investigate those concerns. The manufacturer conducted a post-marketing clinical trial, but it was not designed to assess whether Avandia patients were at higher risk for heart attacks.