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FDA Panel Rejects OTC Cholesterol Drug

Experts Recommend That Mevacor Remain a Prescription Drug
By
WebMD Health News
Reviewed by Louise Chang, MD

Dec. 13, 2007 -- Expert advisors urged the FDA to reject a drug company's bid to sell a cholesterol-lowering drug without a doctor's prescription.

This was a major setback in Merck & Co's years-long effort to sell Mevacor over the counter.

The company maintains that Mevacor is safe and that the potential for consumers to take lipid-lowering medication on their own could greatly reduce rates of heart attacks and strokes.

The FDA ruled against a similar request in 2005, stating that the company had not demonstrated that average consumers can safely and effectively use the drug.

The 2005 ruling caused the company to design new product labels and conduct new studies looking at consumers' ability to fully understand those labels. But old questions returned Thursday, as experts worried that consumers may not use the drugs correctly without the advice of a doctor.

The panel voted 10-2 that Merck should not be allowed to sell Mevacor over the counter. There was one abstention.

"We're not in a position that people can make that safe, informed decision," said Mary E. Tinetti, MD, a professor of medicine at Yale University and the panel's chairwoman.

Mevacor's Track Record

Lovastatin, the active ingredient in Mevacor, has been on sale in the U.S. for 20 years. It is one of the class of prescription drugs called statins, which work by lowering both total cholesterol and low-density lipoprotein (LDL), the so-called "bad" cholesterol.

Heart disease is the No. 1 cause of death in the United States, killing more than 650,000 people per year. More than 25 million Americans have undiagnosed heart disease, according to the CDC.

Millions of patients take statins because they are proven to help lower the risk of cardiovascular events like heart attacks and strokes in patients at risk for coronary heart disease.

But Merck was hoping to use nonprescription status to reach a different group of people: those at moderate risk of heart disease because they have elevated cholesterol.

"Being over-the-counter provides overall better access and awareness," said Jerry Hansen, Merck's executive director of consumer behavior research.

Label Education

A large product label proposed by the company advises prospective buyers on diet and exercise and warns them about potential side effects. It also tells consumers they should go to their doctors at least once a year to get their cholesterol checked.

About 70% of laypeople in a Merck study were able to correctly decide if the drug was right for them using the drug label. But 30% said they would purchase the drug even though they did not meet criteria for using Mevacor. Common reasons were because they were at lower risk for heart disease than they thought, or that they were already taking a statin drug.

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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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