Statement by Sidney Wolfe, MD, Director of Health Research Group at Public Citizen
The New England Journal of Medicine study just released showing a 43 percent increase in heart attacks in people using Avandia should come as no surprise either to the Food and Drug Administration (FDA) or to Glaxo. In animal studies done prior to its approval, one of the most constant findings was damage to the heart, and within the first six years of approval there have been 689 cases of heart failure reported to the FDA in patients using the drug. In addition, there have been reports of anemia which, along with heart failure, increases the risk for a heart attack.
We have warned readers of WorstPills.org since the end of 2004 that they should not use this drug. More recently, there have been numerous reports of visual abnormalities in the form of macular edema (swelling of part of the retina) and increases in several kinds of fractures in women.
Despite prior knowledge of serious cardiac problems, the FDA has failed to require Glaxo to adequately warn about the dangers of this drug that should be, at best, a last-choice treatment for Type II diabetes. In addition to the accumulating evidence of its risks, it is not even as effective as other diabetes drugs in lowering blood sugar or hemoglobin A1C, a measure of glucose control.
Because of inadequate warnings about Avandia and massive advertising campaigns, its popularity has grown so that 11 million prescriptions were filled for the drug in the United States in 2006 alone.
We strongly urge patients – as we have for almost two and a half years – not to use this drug.