U.S. drug regulators are investigating whether the cholesterol-lowering drug Vytorin might be linked to cancer. The U.S. Food and Drug Administration 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.
The FDA has 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, according to the FDA, 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 FDA says 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, according to an Associated Press report.
The FDA 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 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. Several members of Congress have demanded data on the trial. I understand that Merck and Schering-Plough are cooperating with the requests. But the companies defended the drug, saying it is effective at reducing cholesterol — the use for which it was approved – but that doesn’t address the cancer risk issue.
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