The influential consumer group Public Citizen has called on US regulators to ban GlaxoSmithKline’s Avandia, claiming that the diabetes drug causes death from liver failure “and has many other life-threatening risks that far outweigh its benefits”.

Public Citizen says it has filed a petition with the US Food and Drug Administration to remove Avandia (rosiglitazone) from the market based on 14 cases of drug-induced liver failure, including 12 deaths. These cases were derived from the FDA Adverse Event Reporting System after what the group calls a “careful review of the agency’s MedWatch forms, which are submitted to the agency when adverse drug reactions are suspected”.

Public Citizen has previously encouraged diabetes sufferers to avoid taking Avandia because it says that the drug increases the risk of heart attack by approximately 40%, doubles the risk of heart failure and bone fractures and increases the risk of anaemia and vision loss from macular edema. The petition claims that there were 39 times more reports of the latter disease per million prescriptions filled for Avandia than for an older diabetes drug, glipizide.

The petition also notes representatives from the American Diabetes Association and the European Association for the Study of Diabetes have recently “unanimously advised” against using Avandia in Diabetes Care, the ADA’s journal. Avandia prescriptions have fallen sharply since a meta-analysis published in the New England Journal of Medicine in May 2007 connecting the drug with increased heart attack risk, but “approximately 10,000 prescriptions a day are still filled for this unacceptably dangerous drug”, Public Citizen says.

Sidney Wolfe, director of Public Citizen’s Health Research Group, said the “scientific consensus against Avandia is overwhelming,” and these latest findings “should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug”.

GSK is standing firmly behind Avandia and issued a statement saying that “we do not believe there is a connection between liver toxicity and this medicine”. Indeed the firm believes the drug has a favourable liver safety profile, a view backed by “an external panel of independent experts who review any reports of liver issues” and as recently as July “they continued to endorse a favorable hepatic safety profile”.

The company added that Avandia is a safe and effective medicine when used according to the label and data from long-term clinical trials, “which offer the most rigorous scientific measurement of safety and efficacy”, provide substantial evidence to back this up. Furthermore, GSK notes that Avandia is the only thiazolidinediones proven to sustain glycaemic control for up to five years. “In long-term clinical trials, the risk of cardiac ischemic events was similar between Avandia and other commonly used oral diabetes medicines”, the firm concluded.