GlaxoSmithKline P. L. C.'s drug Avandia is facing flak for causing more than one dozen cases of liver failure and death in patients taking the drug according to a consumer advocacy group Public Citizen.

On Thursday Public Citizen called upon the U. S. Food and Drug Administration to take Avandia off the market saying the drug posed life threatening risks including heart and liver damage. Last week the American Diabetes Association, a leading patient-advocacy group, said it was unclear whether Avandia increased heart-attack risks but recommended against using the drug saying there are equally effective treatments available other than Avandia.

The American Association of Clinical Endocrinologists, whose members treat diabetic patients, continues to support using Avandia. It said Avandia has "been shown useful and effective in controlling glucose, a crucial step to preventing diabetes complications."

GlaxoSmithKline defended its drug Avandia, and said that two large, long term studies had shown the drug to be safe. They urged patients currently taking Avandia to remain on the drug unless their doctor advised them against it.

The company in a statement said, "We do not believe there is a connection between liver toxicity and this medicine." They added that they had not yet read the group’s petition.

Public Citizen said in its review of U. S. Food and Drug Administration data they found 14 previously unpublished cases of severe drug-induced liver failure, including 12 deaths. "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 diabetes," the petition said.

In the petition to the FDA they added that the risks as well as other known complications which included heart failure, fractures and vision loss, were severe and wanted the drug banned in the United States.

Zachary T. Bloomgarden, an endocrinologist at Mount Sinai Medical Center in New York, who chaired AACE's recent position statement on Avandia said, "There is currently no evidence of liver concern with Avandia, with most information actually suggesting liver benefit." He has received grants and fees from many drug companies including GlaxoSmithKline.

FDA spokeswoman Karen Riley said they would review the petition. Public Citizen estimates that despite a drop in the drugs sale, about 10,000 prescriptions continue to be filled each day. "Thus, it is urgent for the FDA to immediately ban rosiglitazone," it said.