FDA Panel Rejects OTC Cholesterol Drug
Experts Recommend That Mevacor Remain a Prescription Drug
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
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
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
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
"Being over-the-counter provides overall better access and
awareness," said Jerry Hansen, Merck's executive director of consumer
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
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.