In May, the New England Journal of Medicine linked the diabetic drug rosiglitazine (Avandia, Avandamet & Avandaryl) to heart attacks and heart related deaths. The FDA on Nov. 14th, modified its black box warning to include information about potential increased risk for heart attacks. The FDA warning is confusing however and provides no useful guidance to patients or physicians. The new warning it is felt, should be revised to clearly note that using this drug carries serious risks. Some entities have taken it upon themselves to prevent people from using this drug.
After conducting its own review in October 2007, the Department of Veterans Affairs removed rosiglitazone from the list of drugs its doctors may prescribe, concluding that “for some patients rosiglitazone may not afford the same margin of safety as alternative drug therapies”.
In November, Health Canada, the Canadian equivalent of the FDA, issued broad restrictions on the use of rosiglitazone. It is no longer approved as a single treatment for diabetes or for use in combination with sulfonylureas (except for patients unable to take Metformin). Neither is it approved for patients taking insulin or for patients diagnosed with either past or current heart failure, even if it is mild. Health Canada advises patients to talk about the benefits and risks of continuing therapy, especially those with Heart Disease or at high risk for heart attack or heart failure.
It is felt that the FDA needs to ban this drug from the US market because there is not evidence of any beneficial clinical outcome for this drug and instead growing evidence of unique risks in multiple organ systems. US citizens at risk from heart attack and failure should not take this drug. Until the FDA takes appropriate steps to inform the American public about its dangers, Health Canada remains the sole source of this vital information.
