Survey Report: FDA Should Have Been Tougher on Avandia

11/26/2007- Six out of every 10 (61%) of the 408 respondents to a MedPage Today poll said the FDA should have been tougher when it ordered that a myocardial infarction warning be added to the black box warning for heart failure on the rosiglitazone (Avandia) label.

That action came after months of controversy and congressional hearings sparked by a meta-analysis published online in May by the New England Journal of Medicine, but it fell short of the action taken by Health Canada. The Canadian drug agency limited use of rosiglitazone monotherapy to a select group of patients who are refractory to metformin. The Canadians also barred rosiglitazone's use in those with a history of heart disease.

One physician noted the dilemma physicians and their patients face. "The take-home message about this drug is still quite vague," she said. "The fact is, it reduces glycemia marvelously and most diabetics have a considerable risk of coronary artery disease, so what exactly are we measuring?"