FDA Panel Rejects OTC Cholesterol Drug
Experts Recommend That Mevacor Remain a Prescription Drug
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.