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FDA Date: 12/22/09
Vytorin (ezetimibe/simvastatin) FDA Drug Safety Communication
Follow-Up to the August 2008 Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia)--FDA Investigates a Report from the SEAS Trial
In August 2008, FDA issued an Early Communication describing a possible association between the use of Vytorin--a combination of simvastatin (Zocor) and ezetimibe (Zetia)--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 interim data from two large-scale ongoing cardiovascular trials with Vytorin--the SHARP and IMPROVE-IT trials.
Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death. 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.