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The FDA is investigating a report of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination of Zocor and Zetia and is generally prescribed to reduce LDL-cholesterol levels. A recent study, however, raises an alarming question: Can the use of Vytorin cause cancer?

A clinical study known as the SEAS trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of major cardiovascular problems. A lower cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of people treated with Vytorin were diagnosed and died from all types of cancer, including skin cancer, when compared to placebo during the 5-year study. The FDA is considering, but has not yet reached a conclusion, about whether this information warrants any regulatory action. According to the New England Journal of Medicine, “it is appropriate to raise a note of caution. Whether the increased mortality risk is due solely to the play of chance is uncertain. Ezetimibe [Zetia] interferes with the gastrointestinal absorption not only of cholesterol, but also of other molecular entities that could conceivably affect the growth of cancer cells.”

According to the FDA website, Zocor, a “statin” class drug approved in 1991, decreases production of cholesterol by the liver and is indicated to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events such as heart attack and stroke. Zetia, approved in 2002, inhibits the absorption of cholesterol in the intestine and is indicated to reduce LDL-cholesterols. Vytorin, the combination product, was approved in 2004 and indicated to reduce LDL-cholesterol levels.

Earlier this year, Vytorin’s effectiveness was called into question. A company-sponsored trial known as the “Enhance” trial was meant to prove that Vytorin’s combination of Zetia and Zocor would reduce the growth of fatty plaque in the arteries more than Zocor alone. Instead, the plaque actually grew almost twice as fast in patients taking the combination drug.

These recent studies raise serious questions: Does Vytorin work? Can it actually put you at higher risk for cardiovascular problems? Does it put you at an increased risk of getting cancer?

Links to NEJM articles:

Change of opinion:…
Full SEAS Vytorin trial:…
Gene damage study:…

Links to Canadian Medical Association Journal article:…

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