Mike Derer/AP

More Bad News for Vytorin as FDA Researches Possible Cancer Link

August 22, 2008 01:56 PM
by Cara McDonough
The FDA said it has begun researching whether Vytorin increases cancer risk, but patients should not stop taking the cholesterol-lowering drug.

30-Second Summary

Federal drug safety regulators said that the risk of cancer from taking Vytorin, a combination of Merck drug Zocor and Schering-Plough drug Zetia, is still unclear, and so those taking the drug should not stop.

Clinical trial results released in July showed that in a study of more than 1,800 people, 93 people who took Vytorin developed cancer, compared with 65 in a control group. But two studies currently underway have shown no increased risk, according to the FDA.

Some researchers were quick to say the original cancer finding was most likely an anomaly. Richard Peto, a statistician at Oxford University, said the idea that Vytorin could cause cancer was “a bizarre hypothesis.”

The possible cancer link, however, comes on the heels of another recent clinical trial that showed that the drug failed to improve a heart valve condition called aortic stenosis, which, left untreated, can lead to serious heart problems.

Studies also found that the drug was no better at lowering cholestoral than the much cheaper generic drug, Zocor, a finding that contributed to the debate over brand-name versus generic drugs.

Headline Link: Vytorin gets closer look

Background: Original cancer findings; study shows Vytorin no better than older drugs

Related Topics: Generic vs. brand-name; FDA pushes new drug rules

Reference: Aortic valve stenosis


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