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Health Officials Investigate Possible Vytorin-Cancer Link

Posted by Chrissie Cole
Saturday, August 23, 2008 12:43 AM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Vytorin, Zetia, Zocor, Cholesterol, Dangerous Drugs, Cancer, Statins, Merck & Co, Schering-Plough Corp


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IMAGE SOURCE: © Wikimedia Commons/ Cholesterol/ Author: RedAndr


Food and Drug Administrators are reviewing recently publicized data that suggests a higher rate of cancer in patients taking the cholesterol-lowering drug Vytorin.

Patients are advised to continue taking Vytorin because the cancer link is unclear at this time, said the FDA.

While one recent clinical trial indicated a higher incidence of cancer in patients taking the cholesterol lowering drug, two other studies underway, have not found an increased risk of cancer.

In the meantime, Congress has demanded all data on the clinical trial indicating Zytorin increases cancer risks in some patients.

Vytorin, a combination cholesterol lowering drug, is a joint venture of Merck & Co and Schering-Plough Corp. made up of their respective drugs Zocor (by Merck) and Zetia (by Schering).

The combination statin drug has been the center of controversy following a study earlier this year that found no substantial difference in the composite heart goals between patients who received Vytorin and those given a placebo.

Leaders of the House Committee on Energy and Commerce asked the companies for data on the clinical trial that indicates a possible cancer risk associated with Vytorin use. Both companies said they would comply. They were given two weeks to supply the requested information.

The FDA is reviewing a recent study, titled SEAS, that found an increased risk of cancer and deaths from cancer in patients taking Vytorin, compared with those given a placebo.

Two congressmen, Rep. John D. Dingell and Rep. Bart Stupak, both Democrat’s from Michigan, have been focusing their efforts on Vytorin drug safety issues and marketing practices.

“Vytorin’s effectiveness has been in doubt, and now its safety is questionable,” Stupak said.

The congressmen have several questions. At the forefront of the list are the discrepancies in the number of cancer cases reported by different researchers involved in the Vytorin study.

Vytorin targets patients who are unable to lower their LDL or ‘bad’ cholesterol by diet alone. In addition, Vytorin raises patients’ HDL or ‘good’ cholesterol.

The Journal of the American College of Cardiology recently published a new analysis that included 15 statin studies of more than 90,000 patients that found statin users were no more likely to get cancer than people given placebo drugs.

One way Zetia may be linked to cancer is that it blocks the absorption of plant sterols, said Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. He explained, "There's a body of medical literature that says those very plant sterols can inhibit the growth of cancer."

The investigation is expected to take up to nine months to complete, according to the FDA. #


1 Comment

Anonymous User
Posted by Paulette
Tuesday, August 26, 2008 11:11 AM EST

Since I started vytorin in 2002 I have had lymphoma, Lung cancer, and colon cancer. This might not be linked to vytorin, but I have never had cancer in my family. I did not have any issues before I started taking this drug either. So I will wait for the results, hopefully it is not the reason.

Thanks

Comments for this article are closed.

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