FDA investigates cholesterol drug

WASHINGTON, Aug. 23 (UPI) -- The U.S. Food and Drug Administration said it is investigating a report of a possible increased cancer risk for patients who take the drug Vytorin.

Vytorin is a combination of simvastatin, marketed as Zocor, and ezetimibe, marketed as Zetia. It was approved as a combination drug in 2004 to reduce LDL-choloesterol levels.

Preliminary results of a clinical trial to see if lowering LDL-cholesterol with Vytorin would reduce the risk of major cardiovascular events in patients with aortic stenosis showed 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 said Thursday in a release.

The FDA, however, said interim data from two large ongoing cardiovascular trials of Vytorin show no increased risk of cancer with the combination of simvastatin plus ezetimibe. One trial will be complete in 2010 and the other in 2012.

The FDA said current information "should not prompt patients to stop taking Vytorin or any other cholesterol lowering drug."