The consumer group wants the agency to have the diabetes pill yanked over deaths from liver failures and other life-threatening risks. In a statement, Public Citizen calls Avandia, which is used to treat Type Diabetes 2, “unacceptably dangerous,” and cites new research to justify its petition.

The move comes after the American Diabetes Association and the European Association for the Study of Diabetes last week both advised against using Avandia (look here and here).

To support its position, Public Citizen says it has identified 14 cases of Avandia-induced liver failure, including 12 deaths, which spotted after combing through the FDA’s Adverse Event Reporting System. The consumer group adds that Avandia increases the risk of heart attacks, can double the risk of heart failure and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye. There were 39 times more reports of macular edema per million scrips fillled for Avandia than for an older diabetes drug, glipizide.

Here is the petition. We await word from Glaxo.

This just in from a Glaxo spokeswoman: “We have not had an opportunity to read the Public Citizen report yet but we do not believe there is a connection between liver toxicity and this medicine. We believe there is a favorable liver safety profile. In fact, GSK has an external panel of independent experts who review any reports of liver issues and as recently as July 2008 they continued to endorse a favorable hepatic safety profile.

“Avandia is a safe and effective medicine for appropriate type 2 diabetes patients, when used according to the label. Data from long-term clinical trials, which offer the most rigorous scientific measurement of safety and efficacy, provide substantial evidence to assess the benefit-risk of Avandia in treating patients with diabetes. Avandia is the only TZD proven to sustain glycemic control for up to 5 years In long-term clinical trials, the risk of cardiac ischemic events was similar between Avandia and other commonly used oral diabetes medicines on the market. Current FDA-approved labeling for Avandia says that the available data are inconclusive on the risk of myocardial ischemia.”