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FDA Panel Considering Over-the-Counter Statin
Date:12/13/2007

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 contraindicated for pregnant women.

"What I worry about is that a lot of the people who take statins over the counter will be the so-called 'worried well,' who don't really need a cholesterol-lowering medication," Nissen said.

"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 committee, Dr. Michael D. Maves, executive vice president and CEO of the American Medical Association (AMA) expressed the association's opposition to the Merck proposal for many of the same reasons as Nissen.

"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.

Consumers Union has also lined up against the Merck proposal.

"Consumers Union is urging the FDA to reject Merck's latest application to sell an over-the-counter version of the cholesterol-lowering medicine Mevacor, primarily because high cholesterol can't be self-diagnosed, many people with elevated cholesterol can bring it under control with diet and lifestyle changes, and statins are potent drugs that carry the risk of serious side effects," the group said in a prepared statement.

Another opponent of the proposal hopes the commi
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