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What is the concern about Avandia?

Recently, the New England Journal of Medicine released an analysis by Dr. Nissen linking Avandia to an increased risk of heart attacks as a side affect of Avandia. The analysis was based on data gathered from public sources, and combined 42 studies, a form of research called a meta-analysis.

The analysis showed a 43% higher risk of heart attacks among patients taking Avandia, compared with what Avandia was being compared against in clinical trials. The analysis showed a 64% elevated rate of cardiovascular death, though this didn't meet a standard statistical test for significance. Among people in Dr. Nissen's analysis who took Avandia, the rate of heart attack was between 0.43% and 1.85%, while the cardiovascular-death rate was between 0.14% and 0.51%.

The results of a meta-analysis aren't considered as strong as those from a single large clinical trial. However, Dr. Nissen calls the analysis "very concerning." An editorial that accompanied the analysis in the medical journal said that "regulatory action by the Food and Drug Administration is now warranted," and "the rationale for prescribing [Avandia] at this time is unclear."

GlaxoSmithKline PLC, which makes Avandia, said in a statement that it "strongly disagrees" with the side affect findings, which the company said were based on "incomplete evidence and a methodology that the author admits has significant limitations."