Thursday the U.S. Food & Drug Administration (FDA) announced it is investigating a possible link between the drug Vytorin, manufactured by Merck & Co. and Schering-Plough, and an increased risk of a variety of cancers.

An FDA MedWatch Alert released Thursday, Aug. 21, informed healthcare professionals 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, Merck’s Zocor and Schering-Plough’s Zetia.

Recently, the FDA obtained preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial, which 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 5-year study.

The FDA is continuing its investigation into Vytorin. The agency anticipates receiving a final SEAS study report in about 3 months and the its review and evaluation of the clinical trial data and other relevant information should take approximately 6 months.

In the meantime, the FDA says patients should not stop taking Vytorin, and says the link to cancer is not clear. The FDA does recommend that health care providers monitor patients for possible side effects.

ABC News said that while the recent clinical trial indicates higher rates of cancer for patients taking Vytorin, two other studies currently underway show no link between cancer and statin drugs like Vytorin.

The release of the possible link between Vytorin and increased risk of cancer prompted a demand from Congress for immediate access to clinical trial data.



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