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

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

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

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

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