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FDA advisory board votes against over-the-counter statin
Benefit to patients might not outweigh the risks, panel member said.
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A proposal to offer lovastatin over-the-counter was rejected by an FDA panel, primarily due to the fear consumers might not select the drug appropriately.
“It is not clear that the benefits to patients of lovastatin being over-the-counter outweigh the risks, although the risks are small,” Arthur Flatau, PhD, said during a joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee, held in Silver Spring, Md. “Clearly, there are a lot people who are not on statins and should be on statins; putting the drug over the counter will not increase the number of patients who take it.”
Flatau is a patient representative with the Association of Cancer Online Resource, in Austin, Tex.
Self-selection problematic
The vote was 10-2 against over the counter approval of lovastatin (Mevacor, Merck) with one abstention. This was the third time the FDA advisory panel recommended against allowing lovastatin to be sold on drugstore shelves. The majority of panel members who voted against lovastatin over the counter felt consumers were unable to make a decision regarding whether they should be taking a statin.
Robert E. Taylor, MD, PhD, interim dean, School of Medicine, Howard University, voted in favor of offering the drug without a prescription.
“[Lovastatin] is a safe drug and the label has been improved though it still needs some work,” he said. “I am a bit concerned about people who might be at high risk but I think there is a major problem with elevated cholesterol, and I am willing to take a chance.”
Another member who voted favorably felt that findings from studies were not sufficient to demonstrate significant pregnancy, liver and muscle safety concerns.
“There is no question these drugs lower risk,” Thomas Pickering, MD, DPhil, professor of medicine at Columbia University, said. “The benefits greatly outweigh the risks.”
The American College of Cardiology released a statement against offering the statin over the counter.
“Although statins have tremendous benefits and are effective in many patients, there are risks associated with taking the wrong dosage, not adjusting the dosage after condition improvement and not adhering to specific usage guidelines,” the ACC statement read. “Patients get the best treatment when their progress is monitored, and physician involvement is paramount in ensuring that patients receive optimal medical treatment.”