With little fanfare, Health Canada is telling doctors and other health care workers that Glaxo's diabetes pill can only be used only in rare circumstances, and is no longer approved for use with other common diabetes meds, such as insulin or sulfonylureas. Another caveat - Avandia can't be used in patients with any stage of heart failure, according toinfo posted on the health agency's web site on Nov. 6.
The move comes as the FDA has yet to complete its own review. An agency advisory committee met in July and suggested Avandia carry new safety warnings about heart risks. The panel was convened after a controversial study published in The New England Journal of Medicine contended the pill causes a 43 percent increased risk of heart attack and the FDA is reportedly considering placing a Black Box warning on the label.
The restrictions vindicate the position advocated by Steve Nissen, the Cleveland Clinic cardiologist who co-authored the New England Journal meta-analysis. "The Canadian decision seems very thoughtful. Essentially, they are withdrawing approval of the drug for most previous indications," he writes Pharmalot. "It will still be available for the occasional patient who might benefit, but most usage will cease. I think it is a reasonable compromise short of complete withdrawal."
For its part, Glaxo gave this statement to Bloomberg News: "Patient safety in the use of our medicines is very important to us, and this updated information will assist Canadian physicians in making individualized treatment decisions when managing the chronic and life-threatening disease of diabetes,'' says Rav Kumar, Glaxo's vice president of regulatory and development operations.