FDA investigates possible Vytorin link to cancer

WASHINGTON – Federal drug safety regulators said Thursday they are investigating whether the cholesterol-lowering drug Vytorin can increase patients’ risk of developing cancer.

However, the Food and Drug Administration said patients should not stop taking Vytorin because the evidence of a cancer link is unclear. While one recent clinical trial indicated higher rates of cancer for patients taking the medication, two studies currently under way have shown no increased risk.

Vytorin, a combination of Merck’s Zocor and Schering-Plough’s Zetia, has been heavily promoted as a novel way to reduce cholesterol. Zocor, a statin drug, reduces the amount of cholesterol produced by the liver. Zetia limits the amount of cholesterol absorbed through the digestive system. But the combination became a focus of controversy after a study earlier this year showed it was no better at reducing the buildup of plaque in the arteries than the much cheaper generic Zocor.

Statins lower the levels of LDL-cholesterol, also called ‘bad’ cholesterol because of its role in heart disease. Some previous studies of statins have suggested a link between low LDL levels and a higher risk of cancer. But again, others have not.

Just this week, the Journal of the American College of Cardiology published a new analysis of 15 statin studies including more than 90,000 patients that found statin users were no more likely to get cancer than people given dummy drugs.

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

Ironically, statins a few years ago were being studied as a possible prevention for certain cancers; those studies ultimately found no effect on cancer, good or bad.

The FDA anticipates its investigation will take about 9 months.