FDA Investigates Possible Vytorin-Cancer Link

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Vytorin is made by the drug companies Merck & Co. and Schering-Plough Pharmaceuticals. It's a combination of Merck's Zocor (simvastatin), a statin, and Schering-Plough's Zetia. A report earlier this year found the drug failed to reduce the buildup of plague in arteries any better than the generic drug Zocor.

Following the FDA's announcement Thursday about the possible Vytorin-cancer link, several Congressional lawmakers issued a demand for data on the trial that suggested a potential connection, the AP said.

Merck and Schering-Plough said they would cooperate with the requests. The companies defended the drug, saying it is effective at reducing cholesterol -- the use for which it was approved, the AP reported.

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Earlier this week, researchers who last year reported a possible link between cholesterol-lowering statin drugs and cancer now say that further analysis has disproved such an association.

"The bottom line is that there is no evidence from this work, the largest study published to date, that the cholesterol-lowering ability of statins increases the risk of cancer," said Dr. Richard H. Karas, director of preventive cardiology at Tufts Medical Center and leader of a group reporting the finding in the Journal of the American College of Cardiology.

A little more than a year ago, a report by Karas and his colleagues in the same journal described a slight increase in cancer risk among statin users -- about one extra case per 1,000 people. That finding came from 13 trials that gathered information on side effects reported by people who took the drugs.

The newer report had data from 15 controlled trials involving more than 437,000 person-years of follow-up. The analysis did find a relationship between low levels of LDL cholesterol -- the "bad" kind that clogs arteries and that statins attack -- and a higher incidence of cancer. However, the team concluded that statins, per se, "lack an effect on cancer risk across all levels of on-treatment LDL cholesterol."

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