FDA Can’t Rule Out Vytorin Cancer Link

The Food and Drug Administration says it cannot rule out a possible link between the cholesterol drug Vytorin and cancer-related death.

The FDA announced today it has completed its review of the safety of Vytorin – which is a combination of the drugs Zocor (simvastatin) and Zetia (ezetimibe). The agency launched its investigation in August 2008 to determine whether people taking the drug are more likely to develop cancer or suffer cancer-related death.

The FDA studied the preliminary results of a clinical study of Vytorin, called Simvastatin and Ezetimibe in Aortic Stenosis (or SEAS for short) to reach its conclusion about the health risks of taking the drug.

“Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out,” the FDA said.

The FDA is not advising patients or physicians to stop using Vytorin at this point but said it will continue to evaluate the benefits and risks of the drug compared to other cholesterol-lowering medications. However, the fact that the FDA left the door open as to whether taking Vytorin increases the risks of cancer and cancer-related death is troubling and should give patients reason to question their continued use of the drug.

There was enormous drug-industry pressure placed on the FDA to clear Vytorin, a drug taken by millions of Americans to reduce cholesterol linked to heart disease. The FDA stopped short of issuing a totally clean bill of health for the drug, which speaks volumes about lingering concerns the agency may have about Vytorin and the cancer link.

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