Public Citizen, an advocacy group, said its review of U.S. Food and Drug Administration (FDA) data found 14 previously unpublished cases of severe drug-induced liver failure, including 12 deaths, of patients administered GlaxoSmithKline´s diabetes treatment Avandia.
But GlaxoSmithKline defended its drug, saying its own review by an independent panel earlier this year said the liver risks were acceptable.
In 2007, Cleveland Clinic researchers published an analysis of studies with Avandia, showing that the drug raised heart failure risks by 43 percent. However, in June last year the FDA advisory panel voted 22 to 1 for the drug to be available on the market, although the warnings were included on the label and prospect.
The company denied any connection of the drug with the reports, adding it had not yet read the group's petition.
That risk, coupled with other known complications that include heart failure, fractures and vision loss, was too great to allow the drug to continue to be sold in the U.S., especially with other treatments available, Public Citizen said in a petition to the FDA. The U.S. health regulators said they would review the petition.
Third quarter sales of Avandia (generically, rosiglitazone), part of a new class of drugs to treat type 2 diabetes called glitazones - fell 23 percent to $ 357 million dollars compared to 2007, the company said last week, while nine months´ sales added up to just over $ 1.15 million dollars this year.
However, Public Citizen estimated about 10,000 prescriptions continue to be filled each day. Another similar diabetes drug, troglitazone, was pulled from the U.S. market in 2000 because of liver toxicity. The drug, called Rezulin, was sold by Parke-Davis/Warner-Lambert, which later became part of Pfizer Inc.