From Our 2007 Archives

FDA Panel Rejects OTC Cholesterol Drug

Experts Recommend That Mevacor Remain a Prescription Drug

By Todd Zwillich
WebMD Medical 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.

Panel member Robert E. Taylor, MD, said Mevacor should be sold without a prescription despite evidence that many consumers won't use it correctly.

"I think we've got a major problem with this elevated cholesterol, and I'm willing to take a chance," said Taylor, chairman of the department of pharmacology at the Howard University School of Medicine in Washington, D.C.

But many other panelists said there were too many potential pitfalls in selling Mevacor over the counter. Patients may not accurately identify that the drug is right for them. Once they do, they may not use it correctly. If they use it correctly, they may not use it correctly for long enough. And if they use if for long enough, they could avoid seeing a doctor because of a belief that they were already being treated.

Merck tried to address each of these pitfalls by including a large amount of patient information in its packaging. It included three separate brochures, along with safety information on the outside of the box.

Tinetti, the panel's chairwoman, said she became confused while reviewing the information with Merck officials.

"I'm just thinking of how long it would actually take [to read it]. And then you lose, I lose, my train of thought in this," she said.

SOURCES: Mary E. Tinetti, MD, professor of medicine, Yale University; chairwoman, FDA panel. National Center for Health Statistics. Jerry Hansen, executive director of consumer behavior research, Merck & Co. Robert E. Taylor, MD, chairman, department of pharmacology, Howard University School of Medicine; member, FDA panel.

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