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FDA Investigates Vytorin

Vytorin is a combination of simvastatin (Zocor) and ezetimibe (Zetia). Vytorin reduces the amount of cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.

In August 2008, the U.S. Food and Drug Administration (FDA) issued an Early Communication describing a possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. The Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. FDA has now completed its review of the data from the SEAS trial as well as a review of recent data from two large-scale ongoing cardiovascular trials with Vytorin. Based on the currently available information, FDA believes it is unlikely that Vytorin increases the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out.

FDA is not advising healthcare professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks of Vytorin or Zetia compared to other FDA-approved cholesterol lowering medications. Consumers should talk to their healthcare professional if they have any questions about Vytorin, Zetia, Zocor or the SEAS trial.

For more information about the FDA’s report, click here.

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