The consumer group Public Citizen has called on the Food and Drug Administration to issue an Avandia recall notice over emerging reports that have linked the diabetes drug to at least a dozen cases of fatal liver failure. The group says that these new liver failure cases, combined with previous warnings about the other side effects of Avandia, make the drug too dangerous to be sold in the U.S.
According to the FDA’s Adverse Event Reporting System, there have been at least 14 reported cases of liver failure among patients taking Avandia. Out of these cases, a dozen later proved to be fatal.

Public Citizen says that a recall of Avandia should be issued because there are safer and more effective medications currently available to patients with type 2 diabetes, the type that it is intended to treat. “The scientific evidence against Avandia is overwhelming,” says the group’s director, Dr. Sidney Wolfe. “[The FDA] needs to act swiftly to prevent further needless deaths and health damage by banning this drug.”

Concerns about the danger of Avandia side effects first arose in May 2007, when a study published by the Cleveland Clinic revealed that patients taking Avandia were 43% more likely to suffer a heart attack and 64% more likely to die from heart-related causes. It was later revealed at a Congressional hearing that GlaxoSmithKline, the drug’s manufacture, was aware of these heart risks as early as 2005, but failed to make this information available to the public.