FDA Warns of Possible Cancer Risk with Vytorin


August 22, 2008

August 22, 2008 – The FDA informed healthcare professionals today that the agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer.

Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently the FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the five-year study.

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. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.

The combined Ezetimibe/Simvastatin drug is marketed as Vytorin. Simvastatin is marketed by itself as Zocor, Ezetimibe by itself is marketed as Zetia. Vytorin is made as part of a joint venture of Merck & Co. and Schering-Plough Corp.

For more information: www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2