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Title: FDA Investigating Possible Link Between Ezetimibe/Simvastatin and Increased Cancer Risk
URL: http://www.pslgroup.com/dg/229976.htm
Doctor's Guide
August 21, 2008

ROCKVILLE, Md -- August 21, 2008 -- The US Food and Drug Administration (FDA) is informing healthcare professionals that it is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of simvastatin/ezetimibe (Vytorin) and a potentially increased incidence of cancer.

Recently, the FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with simvastatin/ezetimibe would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with simvastatin/ezetimibe compared with placebo.

However, there was an additional observation that a larger percentage of subjects treated with simvastatin/ezetimibe were diagnosed with and died from all types of cancer combined when compared with placebo during the 5-year study.

The FDA anticipates receiving a final SEAS study report in about 3 months, and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. The FDA will communicate its conclusions and recommendations at that time.

Healthcare professionals and caregivers should continue to monitor patients taking simvastatin/ezetimibe.

The FDA urges both healthcare professionals and patients to report side effects from the use of simvastatin/ezetimibe to the FDA's MedWatch Adverse Event Reporting program:

· On-line at www.fda.gov/medwatch/report.htm
· By returning the postage-paid FDA form 3500, available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
· Faxing the form to 1-800-FDA-0178
· By phone at 1-800-332-1088

SOURCE: The US Food and Drug Administration

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