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FDA - Vytorin Unlikely To Cause Cancer

Posted by Jane Akre
Tuesday, December 22, 2009 10:13 PM EST
Category: Major Medical
Tags: Vytorin, Zetia, Cholesterol, FDA

Vytorin may not be linked to cancer, FDA regulators say, though studies are ongoing.

Vytorin and Zetia Studies Ongoing

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IMAGE SOURCE: ©iStockphoto/ cholesterol lowering drugs/ author: dlerick

It is unlikely that cholesterol drug, Vytorin, and related drug, Zetia, raise the risk of cancer.

That is the good news from the Food and Drug Administation (FDA) for Merck & Co. about its two cholesterol drugs. The FDA adds that a link cannot be ruled out.

Based on its review of data on the drug trial called SEAS, plus interim findings from two large ongoing studies, SHARP and IMPROVE-IT, FDA regulators say they “did not show an increased risk of cancer with Vytorin."

Vytorin and Zetia remain a $4 billion a year franchise for Merck, reports Reuters, although sales dropped 13.8% from one year ago.

A Merck spokesman says the FDA will continue to evaluate the medications and consumers should not stop using them in the meantime.

SHARP is expected to be concluded in 2010 and the other in 2012, at which time the FDA will make a final determination on cancer risk.

The Cancer Link

In September 2008, the editors of the New England Journal of Medicine (NEJM), which had published results from one study and partial results of two others, advised to use Vytorin with caution.

The review did not show a benefit, and scientists have observed there might be a link between Vytorin and cancer. In July, researchers reported that patients taking Vytorin had a 40 percent chance of dying from cancer when compared to those taking a placebo.

Vytorin is a combination drugs made up of Merck’s Zocor, a statin drug, and Schering-Plouugh’s Zetia, a newer cholesterol lowering drug.

The drug was approved by the Food and Drug Administration in 2002 on the basis of drug trials involving 3,900 patients for 12 weeks, not long enough to determine if the drug reduced heart attacks or cardiovascular disease. #


1 Comment

Anonymous User
Posted by patrocinio d.feliciano
Tuesday, January 19, 2010 1:00 AM EST

I am using crestol and ezetrol for the fast four years.my cholesterol level from 6.5mmol/l drop to 1.7mmol/l it works ok.w/out dieting.

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