Update on Rosiglitazone (AVANDIA): More Strikes Against the Drug

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.

Finally, the Food and Drug Administration (FDA) has taken some action: On Nov. 14, it modified its black box warning for rosiglitazone to include information about potential increased risk for heart attacks. The FDA warning is confusing, however, and provides no useful guidance to patients or their physicians. The new warning should be revised to clearly note that using rosiglitazone carries serious risks.

Some entities have taken it upon themselves to prevent people from using the risky drug. In Oct. 2007, the Department of Veterans Affairs, after conducting its own review, 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.”

And on Nov. 6, Health Canada, the Canadian equivalent of the FDA, issued broad new restrictions on the use of rosiglitazone. In Canada, rosiglitazone is now no longer approved as a single treatment for diabetes or for use in combination with a sulfonylurea drug* (except, in either case, for patients unable to take metformin). In addition, it is not approved for patients taking insulin or for patients diagnosed with either past or current heart failure, even if it is very mild. (*Ask your doctor if you are taking a sulfonylurea).

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.

The FDA needs to ban rosiglitazone from the U.S. market because there is no evidence of any uniquely beneficial clinical outcome for the drug and, instead, growing evidence of unique risks in multiple organ systems. U.S. citizens who are at increased risk from heart attacks and heart failure should not take rosiglitazone.

Until the FDA takes the appropriate steps to inform the American public about the dangers of this drug, Health Canada remains the sole source of this vital information.