FDA Investigates Possible Vytorin-Cancer Link

Aug. 23 -- THURSDAY, Aug. 21 (HealthDay News) -- U.S. drug regulators said Thursday that they were investigating whether the cholesterol-lowering drug Vytorin might be linked to cancer.

The U.S. Food and Drug Administration said it has informed health-care professionals that the agency was investigating a report from the so-called Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and an increased risk of a variety of cancers.

Vytorin is a combination drug made up of the compounds simvastatin and ezetimibe that's designed to reduce levels of LDL (bad) cholesterol and cut the risk of cardiovascular problems. It works by decreasing the production of cholesterol by the liver and inhibiting the absorption of cholesterol in the intestine.

In a statement released Thursday afternoon, the FDA said it had obtained preliminary results from the SEAS trial. The trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular problems in people with narrowing of the aorta, the body's largest artery. The five-year trial did not show a reduced cardiovascular risk. But, a "larger percentage of patients treated with Vytorin were diagnosed with and died from all types of cancer combined, when compared to treatment with a placebo," the statement said.

However, the FDA said patients can continue to take the drug. But the agency urged health-care professionals to monitor their patients for possible side effects and report them to the agency. While one recent clinical trial indicated higher rates of cancer for patients taking the drug, the FDA said two studies currently under way have shown no increased risk, the Associated Press reported.

The agency said it expects to receive a final study from the SEAS trial in about three months. It will then take an estimated six months to review and evaluate the trial data.

Vytorin is made by the drug companies Merck & Co. and Schering-Plough Pharmaceuticals. It's a combination of Merck's Zocor (simvastatin), a statin, and Schering-Plough's Zetia. A report earlier this year found the drug failed to reduce the buildup of plague in arteries any better than the generic drug Zocor.