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Merck Recalls Cholesterol Drug Liptruzet

Packaging problem could allow air, moisture to affect drug's effectiveness, company says

WebMD News from HealthDay

By Dennis Thompson

HealthDay Reporter

TUESDAY, Jan. 14, 2014 (HealthDay News) -- Packaging defects have prompted a recall of a combination cholesterol drug called Liptruzet, produced by Merck & Co., temporarily affecting the entire U.S. stock.

Merck said the foil pouches holding Liptruzet pills could allow air and moisture inside, potentially decreasing the drug's effectiveness.

The recall covers all four dose strengths and every batch that's gone out since Liptruzet hit the market in May.

Liptruzet combines two medications that work together to reduce "bad" cholesterol levels:

  • Atorvastatin, the generic version of the widely used cholesterol medication Lipitor, which reduces the body's natural cholesterol production, and
  • Zetia (ezetimibe), a Merck-produced drug that decreases the amount of cholesterol absorbed from food.

Cardiologists expect no health problems to result from the recall, in part because both atorvastatin and Zetia will remain available separately.

"Patients are not going to be in any harm's way just going on atorvastatin until this packaging issue gets corrected," said Dr. Kevin Marzo, chief of cardiology at Winthrop-University Hospital in Mineola, N.Y.

Marzo added that since the drug has been out for just a matter of months, it's unlikely that doctors have been prescribing it widely.

If a doctor feels a patient needs the combination treatment, then the doctor can prescribe both drugs individually and the patient can take two pills, said Dr. Deepak Bhatt, executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center, in Boston.

Patients can continue to take any Liptruzet they already have on hand, according to Merck, and should talk with their doctor before they quit taking it.

Bhatt said the real risk of this recall is that patients will hear about it and stop taking their cholesterol medication altogether.

"It should be relatively simple and even cheaper to substitute atorvastatin," Bhatt said. "Bottom line, this is something that can be addressed in a relatively straightforward way. The key is not to say, 'Well, I don't have to take anything in its place.'"

Liptruzet and Zetia each cost more than $5.50 per pill, while atorvastatin costs about a quarter per pill.

Merck said it plans to get Liptruzet back on the market as soon as possible.

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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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