FDA to Review Vytorin for Possible Cancer Risk

By Anna Boyd
14:00, August 22nd 2008
69 votes
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A recent study on cholesterol-lowering drug Vytorin, called SEAS, linking it to an increased risk of cancer made the US Food and Drug Administration announce a thorough analysis on the drug, a notice posted on the FDA’s Web site reads.

However, the agency said patients should not stop taking Vytorin because there is not sufficient data to declare it dangerous. Two large ongoing trials involving Vytorin showed no increased risk of cancer.

American Cancer Society epidemiologist Eric Jacobs sustained the same idea. “Nobody should avoid taking a statin because of concerns about cancer,” he said.

Vytorin is made by a joint venture of Merck & Co.’ Zocor and Schering-Plough Corp. The drug reduces the amount of cholesterol produced by the liver. Mary-Fran Faraji, a spokeswoman from Schering-Plough, said the SEAS study had more cancer cases because it included a longer period of patient follow-up. She also added that the FDA investigation was expected.

The SEAS study was originally meant to determine whether Vytorin could help prevent a worsening of heart valve disease, but it did not.

What is ironic is the fact that statins were being studied a few years ago as a possible prevention for certain cancers, but those studies found no effect on cancer, good or bad.

The FDA estimates that it will take the agency three months to receive final results from the SEAS study and another six months to complete its review and draw any conclusions.

Detailed results of the SEAS study will be presented at a cardiology conference in Munich on Sept. 2.



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