FDA Panel Considers Allowing Over-the-Counter Sales Of Low-Dose Cholesterol Medication

Main Category: Cholesterol
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Dec 2007 - 11:00 PST

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An FDA advisory committee on Thursday will meet to consider an application from Merck to market the 20-milligram dose of the anticholesterol medication Mevacor over the counter, the Newark Star-Ledger reports (Todd/Cohen, Newark Star-Ledger, 12/12). The application marks the third time that Merck has sought to make Mevacor the first statin sold over the counter in the U.S. According to a preliminary review released on Tuesday by FDA, although Mevacor appears "reasonably safe and effective" for patients at moderate risk for heart disease when used properly, studies conducted by Merck do not indicate that "there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product" without the advice of a physician.

The studies found that 20% of participants correctly answered all of the questions about whether they should take Mevacor, a rate that increased to 50% when researchers included participants who said they would consult a physician about some of the questions before they purchased the medication, according to the review. In addition, the studies found that 30% of participants with heart disease, diabetes or a history of stroke said that they would purchase Mevacor over the counter, although such individuals require care from a physician, the review found.

Merck said that most participants who did not correctly answer all of the questions about whether they should take Mevacor still could determine whether they should take the medication (Neergaard, AP/Long Island Newsday, 12/11). According to Merck, 72% participants had the ability to determine whether they should take Mevacor. Merck said, "We are confident that the data we will present on Thursday will demonstrate that consumers can safely and effectively use" the Mevacor sold over the counter (Corbett Dooren, Wall Street Journal, 12/12).

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