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Avandia Linked to Increased Risk of Heart Attack

Avandia (generic: rosiglitazone maleate), the popular diabetes drug manufactured by GlaxoSmithKline, has been linked to a high risk of heart attack and death. Avandia has been prescribed to more than 6 million Americans since its approval. It is indicated for the treatment of type 2 diabetes (also referred to as adult onset diabetes). In type 2 diabetes, the body either does not produce enough insulin, or the body is less sensitive to insulin. Avandia reduces the body’s resistance to insulin but also causes fluid retention, which has been identified as a risk factor for congestive heart failure. On June 6, 2007, the FDA announced that it would require a black box warning, the agency’s strongest, on Avandia’s label about the risk of heart attack and other cardiovascular problems. A doctor and medical researcher who testified at Congressional hearings on Avandia the first week of June 2007 revealed that he was threatened with a lawsuit by a GlaxoSmithKline (SmithKline Beecham) executive after voicing his concerns about Avandia’s safety in 1999.

Avandia Research

The FDA issued a safety alert about Avandia on May 21, 2007. The safety alert was in response to a study and editorial published in The New England Journal of Medicine showing that the drug carries a 43% increased risk of heart attack and a 64% increase in the risk of death from all cardiovascular causes. The researchers, Steven E. Nissen, M.D., and Kathy Wolski, M.P.H. of the Cleveland Clinic, looked at clinical trials including 15,560 patients on Avandia and 12,283 in control groups. They found 86 heart attacks in the Avandia group versus 72 in the control group, and 39 deaths from heart disease among Avandia patients versus 22 among the control group. Some feel that the Avandia risks have long been known; an internal government memo from July 2002 warned that Avandia might be linked to congestive heart failure.

In the fall of 2006, GlaxoSmithKline provided the FDA a meta-analysis of 42 clinical trials involving Avandia (rosiglitazone maleate), Avanadamet (rosiglitazone with metformin) and Avandaryl (rosiglitazone with glimepiride). The meta-analysis found a 30% to 40% greater risk of heart attack and other cardiovascular adverse events in patients treated with rosiglitazone than patients in a control group (placebo or other diabetes drugs). The FDA is examining the data of the 42 individual trials. In 2006, the FDA updated Avandia’s label to include a warning about increased risk of heart attacks and chest pain.

Avandia Patients Have Legal Rights

Did you or a family member take Avandia and suffer from a heart attack or another cardiovascular problem?

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