FDA Panels to Evaluate Avandia Heart Risks

Two Food and Drug Administration advisory panels will meet to discuss the results of a study done by Cleveland Clinic cardiovascular medicine chairman and a leading author, Steven Nissen, claiming that the popular diabetes drug "Avandia" may increase the risk of heart attack in patients.

Nissen’s study is based on 42 clinical trials. Results showed that people on Avandia were at 43% higher risk of having a heart attack.

Glaxo, the drug maker, reported a fall of 23% in Avandia sales after the study was published.
The advisory panel may recommend anything from no action to a black box label. However, Glaxo spokeswoman Mary Anne Rhyne maintains that these drugs are safe and the decline in sales is only in new prescriptions.

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