Ban diabetes drug Avandia: consumer group to FDA

The diabetes drug Avandia should be banned over its risks of heart and liver damage, a U.S. consumer group urged.

In a petition filed with the U.S. Food and Drug Administration on Thursday, the group Public Citizen called for the Type 2 diabetes drug, whose generic name is rosiglitazone, to be pulled from the market.

Last week, the American Diabetes Association and a European counterpart unanimously advised doctors against using Avandia in updated treatment guidelines.

"The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities," Public Citizen said in its petition.

"Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure."

In November 2007, GlaxoSmithKline Inc., the manufacturer of rosiglitazone, updated its prescribing information in consultation with Health Canada after a study published in the New England Journal of Medicine reported a 43 per cent higher risk of heart attack for those taking rosiglitazone compared to people taking other diabetes drugs or no diabetes medication at all.

Public Citizen said its has identified 14 cases of liver failure linked to Avandia, including 12 deaths, based on its analysis of suspected adverse drug reactions sent to the FDA.

"In addition there is clear previous evidence of increased risk of heart attacks, heart failure, bone fractures, anemia and macular (retinal) edema with vision loss," the petition said.

Safer, more effective drugs for Type 2 diabetes include metformin (sold in Canada under the brand names Glucophag Glumetza or in generic forms with "metformin" as part of the name) and glipizide (brand name Glucotrol), Public Citizen said.

"We do not believe there is a connection between liver toxicity and this medicine," the company said in a statement.

In the statement, Glaxo said it does not believe Avandia causes liver failure and that a review by an independent panel earlier this year said the liver risks were acceptable.

The company added heart attack data is inconclusive and that Avandia is safe and effective, when used as directed.

There was no immediate response from the FDA.