FDA Advisers Reject Over-the-Counter Statin

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Nissen also noted that statins need to be taken regularly to be effective, but data indicate that over-the-counter medications are not usually taken consistently. Moreover, statins can have rare but serious side effects, such as liver abnormalities, and are not recommended for pregnant women.

"This is not a disease that you can treat with a one-size-fits-all approach. That's what's being attempted here with a 20 milligram, low-dose statin," he said. "I see no public health advantage in doing this, and I see lots of potential problems."

In a letter to the FDA advisers, Dr. Michael D. Maves, executive vice president and CEO of the American Medical Association, expressed the association's opposition to the Merck proposal for many of the same reasons as Nissen.

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"The AMA strongly opposes the Rx-to-OTC switch of Mevacor (lovastatin) as a cholesterol-lowering agent. While the AMA recognizes there is an underutilization of statins to treat hypercholesterolemia in this country, we do not believe that moving a statin to OTC status is the solution. To potentially lose the benefits of physician supervision by switching statins to OTC status would, in the AMA's view, be detrimental to the health of many individuals and to the public," Maves wrote.

To answer such objections, Merck had said that Mevacor's package would promote using the drug as part of an overall program and under a physician's advice.

"The people who would be the candidates for over-the-counter Mevacor are people who have had blood tests and know they have elevated cholesterol that should be treated," said Merck spokesman Ron Rodgers.

Following Thursday's vote, Merck's Edwin L. Hemwall, vice president of global OTC regulatory and scientific affairs, released a prepared statement that said: "We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider."

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