MORE STRIKES AGAINST AVANDIA: THE VA AND CANADA

November 19, 2007

In May, a study in the New England Journal of Medicine linked the diabetes drug rosiglitazone (AVANDIA, AVANDAMET and AVANDARYL) to heart attacks and heart-related deaths. But the heart risks of this drug should not have been a surprise.

Public Citizen has long warned about the dangers of using the glitazone class of diabetes drugs, beginning with our petition to the Food and Drug Administration (FDA) in 2000 for better warnings. We have classified rosiglitazone as a Do Not Use drug for the past three years.

Since the release of the New England Journal of Medicine study, the following actions have been taken:

1. In October, the Department of Veterans Affairs, after conducting its own review, removed rosiglitazone from its formulary (the drugs that its doctors may prescribe), concluding that, "for some patients, rosiglitazone may not afford the same margin of safety as alternative drug therapies."
    
2. On November 6, 2007, Health Canada, the Canadian equivalent of the U.S. FDA, issued broad new restrictions on the use of rosiglitazone.
   
   In Canada, rosiglitazone is now no longer approved either as a single treatment for diabetes (except for patients unable to take metformin), or for use in combination with a sulfonylurea* except when patients are unable to take metformin.
   
   Furthermore, Health Canada warns that rosiglitazone should not be used in any of these situations: in patients taking insulin, in combination with metformin and a sulfonylurea drug, or in patients diagnosed with any degree of heart failure, either past or current, even that which is very mild (NYHA Classes I, II, III, or IV).
   
   Health Canada advises patients to talk to their doctors about the benefits and risks of continuing therapy, especially those with heart disease or at a high risk for a heart attack or heart failure.
    
3. Shortly after the Canadian warning, on November 14, the FDA modified its black box warning for rosiglitazone concerning heart attacks, but in a most confusing fashion: it cites four analyses. One of the four is a meta-analysis of 42 studies which showed an increased risk of heart attacks; the results of the three others "have not confirmed or excluded this risk," according to the FDA. This is inaccurate and provides no useful guidance to patients or their physicians.

The FDA needs to immediately publish an alert similar to that of Health Canada to warn U.S. citizens who are at increased risk from heart attacks and heart failure not to take rosiglitazone. Until then, Health Canada remains the sole source of this vital information.

We continue to label Avandia as a Do Not Use drug.

Learn more:

Read our July 2007 article about the risk of heart problems with rosiglitazone.

See the new Health Canada restrictions on rosiglitazone.

*Examples of sulfonylurea drugs are glyburide, glimepiride, and tolbutamide. Ask your doctor if you are taking these or any other drugs in this class.