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FDA panel says Vytorin and Zetia probably don't cause cancer

December 24, 2009 |  2:55 pm

A comprehensive review of previous studies involving the cholesterol-lowering drugs Vytorin and Zetia and two large ongoing studies shows that "it is unlikely that [they] increase the risk of cancer or cancer-related deaths," a Food and Drug Administration review committee has found. Zetia is the brand name for the drug ezetimibe, which blocks the absorption of cholesterol in the intestines. Vytorin is a combination of ezetimibe and simvastatin, which blocks the production of cholesterol by the body.

At least two studies have shown that Vytorin lowers cholesterol levels better than simvastatin alone but that such lowering does not translate into a reduced buildup of plaque in the arteries or to a reduced risk of heart disease. Those studies have, however, hinted that the drug increases the risk of cancer. That increase is presumably associated with ezetimibe.

The FDA analysis concluded that:

-- Animal studies do not show a risk of cancer associated with ezetimibe.

-- A large body of evidence shows no cancer risk with simvastatin.

-- The risk of cancer did not increase over time in the studies, as would be expected if the drug caused cancer or promoted the growth of preexisting cancers.

-- The cancer risk in the studies involved a wide variety of cancers, which would not be the case if the drug were causing them.

The two ongoing trials are expected to be completed in 2010 and 2012. Until then, the FDA simply advises physicians to use their best judgment in evaluating potential risks and benefits of the drugs.

-- Thomas H. Maugh II

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