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Volume 358:2728-2732 June 19, 2008 Number 25
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Over-the-Counter Sales of Statins and Other Drugs for Asymptomatic Conditions
Mary E. Tinetti, M.D.

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Merck recently submitted its third application to the Food and Drug Administration (FDA) to allow it to sell its cholesterol-lowering drug lovastatin in 20-mg tablets over the counter.1,2 Targeted consumers are men over the age of 45 years and women over the age of 55 years who have levels of low-density lipoprotein (LDL) cholesterol of 130 to 170 mg per deciliter and an intermediate 10-year risk of a cardiovascular event (5 to 20%) but no previous event.1 Merck's arguments for the switch from prescription-only to over-the-counter sales focused on the "treatment gap" — at-risk persons who are not receiving therapy . . . [Full Text of this Article]

Problems with Nonprescription Statins

Inability of Consumers to Self-Select Drugs

Concern about Monitoring

Advertising and Marketing

Need for Oversight


Source Information

From the Departments of Internal Medicine and Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT.


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