Safety Alerts & Recalls

What does this mean?

Based on the currently available information, the FDA is not advising patients to stop using Vytorin or Zetia. However, if you take Vytorin or Zetia, you should review with your doctor the clinical benefits and potential risks of Vytorin or Zetia compared to other FDA-approved cholesterol lowering medications and added lifestyle changes. You may be able to see similar benefits from other FDA-approved cholesterol lowering medications and lifestyle changes such as diet and increased physical activity. Please talk to your healthcare professional if you have any other questions about Vytorin, Zetia, Zocor or the FDA review of the safety information from the SEAS trial.

Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia)

The FDA has concluded its safety review of the possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. Vytorin is a combination of two medications, simvastatin (Zocor) and ezetimibe (Zetia), and is used to lower cholesterol. The review was first announced in August 2008 as part of an FDA Early Communication prompted by early results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. The FDA has now completed its review of the data from the SEAS trial as well as a review of available data from two large-scale ongoing cardiovascular trials with Vytorin - the SHARP and IMPROVE-IT trials. Based on the currently available information, the FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out.

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Source: FDA
Publication Date: 2009-12-23
Last Updated: 2009-12-23

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