May 21 - Evidence confirms Public Citizen's warnings about the risks of popular diabetes drug Avandia

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.


Avandia Update: May 22, 2007

An internal FDA memo written nearly five years ago showed that FDA scientists recommended that labels for Avandia and Actos, another widely prescribed diabetes drug, be amended to include mention of post-marketing reports of heart failure among patients taking the two drugs. To date, the label hasn’t changed.

“The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen. “As a result, millions of people – to the detriment of their health – are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.”

The July 16, 2002, memo shows that, at the time, the FDA had 47 adverse reaction reports in which the use of Avandia (25 cases) and Actos (22 cases) resulted in hospitalization for heart failure. As of last fall, the number of such cases had increased to 803 (415, Avandia; 388, Actos). The total number of prescriptions filled for Avandia and Actos in 2006 was 22 million (11 million for each).

The FDA should either put a black-box-warning on Actos and Avandia or ban them altogether. The post-market drug safety review division should be independent from the rest of the Center for Drug Evaluation and Research. Legislation to make the safety review division independent was introduced this year by Sens. Chris Dodd (D-Conn.) and Charles Grassley (R-Iowa) but was not included in legislation recently passed by the Senate. The bill has not yet passed the House, which could make this change.

READ our letter to FDA Commissioner Andrew von Eschenbach describing the memo

READ the 2002 internal FDA memo.