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FDA Investigating Possible Link Between Ezetimibe/Simvastatin and Increased Cancer Risk 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 E-mail this page to a friend or colleague! To print, use this version