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

Experts oppose idea on medical and safety grounds

THURSDAY, Dec. 13 (HealthDay News) -- For the third time in seven years, a U.S. Food and Drug Administration advisory panel has been asked to recommend making Merck & Co.'s statin drug Mevacor available over the counter.

But with groups such as the American Medical Association, Public Citizen and Consumers Union lined up against it, experts think Merck's proposal is likely to be rejected once again when the panel meets on Thursday.

"The third time is not the charm," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. "It's time to move on."

Merck's proposal is being presented to a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee. The FDA does not have to follow the advice of its advisory panels, but it usually does.

In its proposal, the Whitehouse Station, N.J.-based pharmaceutical giant noted that many people with high cholesterol go untreated, increasing the risk for heart attack and other heart problems.

"The availability of a statin without a prescription is anticipated to help narrow the cholesterol treatment gap," Merck stated. "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."

However, in 2000 and in 2005, the FDA rejected similar proposals because of concerns about how the drug would be used by consumers, potential side effects, and the need to monitor the people taking statins.

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