GlaxoSmithKline PLC’s diabetes drug faces harsh criticism as the Washington, D.C.-based group Public Citizen has recently linked it to liver failure. The group says it has identified 14 cases of Avandia-related liver failure, including 12 deaths.

Conclusively, it urges the FDA to “act swiftly to prevent further needless deaths and health damage by banning this drug,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a statement, appearing in the current issue of Diabetes Care.

In November 2007, Avandia received a black box warning because increased risk of heart attacks in diabetes patients. The drug increases the risk of heart attack by 40 percent, doubles the risk of heart failure and bone fractures, increases the risk of anemia and vision loss from macular edema, according to Public Citizen. 

However, the drug continues to be prescribed for lowering blood sugar in diabetes patients because the FDA concluded the inherent risk of heart attack wasn’t any greater than that associated with other similar medications. Liver toxicity is the latest problem linked to Avandia.

On the other hand, Mary Anne Rhyne, a spokeswoman for the London-based GSK considers Avandia to be safe for appropriate type 2 diabetes patients when used according to the label.

“We do not believe there is a connection between liver toxicity and this medicine,” she said.

Rita Chappelle, an FDA representative, said the agency will review Public Citizen request and respond.