Consumer watchdog urges immediate Avandia ban

November 3rd, 2008 by Kurt Niland

Consumer watchdog group Public Citizen released a petition on Thursday calling for an immediate ban on ’s drug Avandia. In a petition addressed to Commissioner Dr. Von Eschenbach of the U.S. Food and Drug Administration, Public Citizen urged the ban based on trial data revealing the drug’s “multiple, serious risks.”

The group enumerated its concerns in a full petition, citing both safety and efficacy issues. Adverse events linked to and listed in the petition include liver failure, myocardial ischemia (increased risk of ), congestive heart failure, macular edema (vision loss), anemia, and bone fractures.

One new analysis of the FDA’s Adverse Event Reporting System (AERS) data revealed that of 14 users who experienced kidney failure, 12 died.

“The evidence for this unique combination of toxicities is compounded by the accompanying lack of evidence of any clinical benefit, compared to other approved drugs for ,” the petition states.

The petition also refers to statements released earlier by both the American Diabetes Association and the European Association for the Study of Diabetes advising against the use of given the availability of better options.

To support its claim, Public Citizen also included a graph highlighting the dwindling sales of from the first quarter of 2006 to the second quarter of 2008. 13.3 million prescriptions were written in 2006, yet only 4.6 million were written in the last year. prescriptions have declined steadily since late 2006.

“The FDA is in possession of clear, unequivocal evidence that () causes a wide variety of toxicities,” Public Citizen said in its petition to the FDA.

Drugmaker issued a response to the petition on Friday, standing by .

“The safety of patients using our medicine is very important to us. On a continual basis, an external Hepatic Safety Board reviews any adverse event report received by GSK of liver failure, liver-related deaths and liver transplants for possible relationship to . As recently as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for ,” the statement said.

Public Citizen is a nonprofit consumer advocacy organization representing more than 80,000 consumers in the U.S. It was founded in 1971 to “represent consumer interests to Congress, the executive branch, and the courts.”

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  • W.E. Feeman, Jr, MD
    I am a family physician who, for the last 35 years, has directed an aggressive screening clinic for the primary and secondary prevention of atherothrombotic disease (ATD), which includes heart attacks and heart failure, as well as strokes, aortic aneurysms, etc. The screening evaluation includes a lipid profile, two-hour postprandial glucose, blood pressure, and most importantly cigarette smoking status. The tool is an accurate predictor of the population at risk of ATD. Since most diabetics have lipid abnormalities long before their sugar levels rise, I see "diabetics" long before they actually become diabetic. I treat their asociated ATD risk factors to goal, and so when the blood sugar rises, I simply add on a medication to lower the sugar. As a result of this program, the average age of death in my never-smoking diabetics is 80 years of age. I presented this data at the 2003 annual scientific symposium of the American Academy of Family Physicians in New Orleans. More recently, I presented data at the 2009 scientific symposium of the International Atherosclerosis Society in Boston to show that the prediction of the population at risk of ATD is independent of blood sugar level, and I will present this data again in Hamburg at the 2010 scientific symposium of the Eauropean Atherosclerosis Society in June. I use Avandia because it is less expensive ($100/month less expensive) than Actos, which I also use at times. To date no diabetic patient of mine treated with Avandia has sustained a heart attack or gone into heart failure. The reason why is probably that I treat intensely the diabetic's associated ATD risk factors. Because of the expense of Actos, I am not planning on ceasing to prescribe Avandia.
  • Lewie Smith
    I would like to know if these results are taken from patients who have been long term users of avamdia. I have been taking Avandia for 10 years. Would you advise me to talk to my Dr, about an alternative medication?
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