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Should Patients Stop Taking Avandia?

The Food and Drug Administration said that it is "aware of a potential safety issue" related to Avandia. But the FDA added that other published and unpublished data provide "contradictory evidence" about the drug's risks, and that the FDA is analyzing of all available data.

Last year, the FDA required a labeling change for Avandia to include a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals -- based on a trial in patients with existing congestive heart failure.

In a joint statement, the American Heart Association, American College of Cardiology and American Diabetes Association said the study "deserves serious thought and follow up" though the overall level of risk associated with the drug "appears to be small." The groups said patients should not stop taking any prescribed drugs without talking with their health-care providers.

Dr. Kirkman of the American Diabetes Association noted that diabetics are at a high risk for cardiovascular problems. However, she said, "We don't feel that this is an emergency or a panic situation, and we certainly don't advise that people go off medication without talking to their health-care provider about alternatives," she says.

Richard Hellman, president of the American Association of Clinical Endocrinologists, said Dr. Nissen's study raises the possibility that certain patients, such as those who have heart disease, may be at especially high risk. He said, the association isn't recommending that doctors stop prescribing Avandia altogether.