The Food and Drug Administration (FDA) is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, which demonstrates a possible link between the drug Vytorin and an increased incidence of cancer. Vytorin is a combination drug that contains the statin simvastatin (Zocor) and the selective cholesterol absorption inhibitor, ezetimibe (Zetia). Preliminary data from the SEAS trial, which tested whether lowering low-density lipoprotein (LDL) cholesterol with Vytorin would decrease the risk of cardiovascular events in patients with aortic stenosis, showed no reduction in cardiovascular risk with Vytorin. However, an increased number of study participants were diagnosed with and died from various types of cancer when compared with those receiving placebo during the 5-year study.
   The FDA will evaluate the clinical trial data after they receive the final report from the SEAS trial sponsors and then release public recommendations.
   An elevated LDL-cholesterol level is a risk factor for heart disease. Lowering cholesterol decreases the risk of death from heart disease and stroke. Therefore, patients shouldn't stop taking Vytorin or other drugs that lower cholesterol. Health care providers should continue to monitor patients taking Vytorin according to the manufacturer's prescribing information.

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