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Is Vytorin Cancer Risk Real?

FAQ: Why Congress and the FDA Are Investigating Vytorin
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Why Is the FDA Investigating?

It's the FDA's job to ensure drug safety. And it probably didn't hurt that a U.S. congressional committee led by Rep. John Dingell (D-Mich.) demanded a look at the data just hours before the FDA said it would investigate.

Merck and Schering-Plough tell WebMD that they are cooperating fully with both the FDA and Congress.

But doubts remain. Still unexplained are the extra cancer deaths in patients taking Vytorin, says Nissen.

In a statement, Merck says the data show "a non-significant increase in deaths from cancer in patients in the group who took Vytorin compared to those who took placebo."

Nissen disagrees. He says the difference is highly significant and very unlikely to have occurred by chance, as Peto asserts.

"The SEAS, SHARP, and IMPROVE-IT trials, taken together, show an excess of cancer mortality associated with the Zetia-containing product Vytorin: 136 cancer deaths in treated patients vs. 95 cancer deaths in the control arms," Nissen tells WebMD.

Nissen is quick to add that the studies do not prove Vytorin causes cancer.

"The jury is still out on whether Vytorin or Zetia is associated with an increased risk of cancer," he says. "Therefore, we need careful evaluation of all the data by independent physician scientists and the FDA. And we need to be cautious about prescribing this drug until we have more data."

The FDA and the American Heart Association have warned patients not to stop taking any cholesterol-lowering drug without talking with their doctors.

How Might Vytorin Up Cancer Risk?

Vytorin contains Zocor, a statin drug -- and statin drugs do not cause cancer.

Pointing to this data, Peto says there's absolutely no reason to suspect that Vytorin can cause cancer.

"This isn't the sort of drug that is expected to have any material effect on cancer," he said at the July 21 press conference.

But Vytorin also contains Zetia. Zetia blocks absorption of cholesterol in the gut. It also blocks uptake of plant sterols, one of the healthful byproducts of eating vegetables.

In animal studies, plant sterols have an anti-cancer effect. One study shows they keep tumors from spreading.

Is This Normal? Get the Facts Fast!

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Desirable
0-199
Borderline
200-239
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240+

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Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is optimal.

Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is near optimal.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is borderline high. If your LDL goes higher, your total cholesterol level could become Borderline High. Consider reducing the amount of foods you eat with saturated fats and increasing physical activity. If you get more exercise, your level of "good" HDL cholesterol may increase, which could also help to keep your levels of LDL and total cholesterol in check.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL. The HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is Very High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL because the HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is Borderline High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.

Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.

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