On December 11, 2007, a study published in the Journal of the American Medical Association concluded that older patients treated with Avandia had a significantly increased risk of suffering from a heart attack or dying. The findings mirror earlier studies, which also linked Avandia and cardiac risks.

The new study found Avandia patients had a 60 percent increased risk of heart failure, a 40 percent increased risk of heart attacks, and a 30 percent increased risk of death. This research also suggests that for every 100 people taking Avandia over a four-year period, there would be five additional deaths, four additional heart attacks, and three additional episodes of heart failure.

“Our study suggests that, at least in this high-risk population, the harms of the drug may outweigh the benefits,” said Dr. Lorraine L. Lipscombe, lead author of the study.

In May 2007, Dr. Steven E. Nissen from the Cleveland Clinic published a study suggesting Avandia patients had a 42 percent increased risk of heart attack. After reviewing Nissen’s study, the Food and Drug Administration (FDA) said in November 2007 that the evidence was inconclusive, and allowed Avandia to remain on the market with a “black box” warning on the label.

“As you accumulate more and more evidence that Avandia has this problem and it involves a very serious consequence, namely heart attack and death, it puts a lot of pressure on the FDA to do more,” Nissen said.

The FDA, however, is standing by its earlier decision.

“This new study we have just seen today does not change the FDA’s recommendations,” read a statement from the agency, adding that the data is inconclusive.

Source: “Study adds to Avandia doubts,” News and Observer, December 12, 2007.