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FDA Advisers Reject Over-the-Counter Statin
Date:12/13/2007

sterol treatment gap," Merck said in a prepared statement. "Consumers already attempt to manage their cholesterol by purchasing unproven food and dietary remedies, and the availability of an OTC statin would give them the option of purchasing an effective pharmacologic therapy. Mevacor Daily [lovastatin 20 mg] is an appropriate choice for an OTC statin. The efficacy and safety of lovastatin has been well-established through the 20 years of marketed use of the product as well as by the post-approval megatrials."

Some experts agree with the idea of over-the-counter statins.

"There is a public health benefit in making statins available over the counter," said Dr. Antonio M. Gotto Jr., a dean and professor of medicine at Weill Cornell Medical College in New York City, a former president of the American Heart Association, and a consultant for Merck.

Statins are safe and effective, Gotto said. "In addition, the American population has reached the point where they are able to assume a greater degree of responsibility for their own health care," he said.

However, a preliminary FDA report released Tuesday concluded that the Merck proposal should be rejected, in part over worries that consumers would not be able to safely judge whether they were good candidates for the drug.

According to that report, Mevacor could be "a reasonably safe and effective" option -- if consumers used it properly. But studies done by Merck failed to show that most people could judge if they needed the drug or not. In addition, some 30 percent of those who said they would buy the drug over the counter have heart disease or diabetes or had had a stroke -- conditions that need a doctor's care, the report said.

The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.

Dr. Sidney Wolfe
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