Statins and Over-the-Counter Availability

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Abstract
Approximately 1000 active ingredients are currently in use in more than 100,000 over-the-counter medications in the United States, with combined annual sales exceeding $17 billion. Many drugs have recently been switched from prescription to over-the-counter status; other such switches have been proposed and rejected, in decisions that have sometimes been controversial. Drugs that have been approved by the Food and Drug Administration (FDA) for shifts to over-the-counter status include some nonsteroidal antiinflammatory drugs (such as ibuprofen, naproxen, and ketoprofen), histamine2-receptor blockers (such as cimetidine, ranitidine, and famotidine), topical antifungal agents, and nicotine-based smoking-cessation products. Recent controversial decisions include those regarding nonsedating antihistamines (switched by the FDA despite objections by the manufacturers), hormonal postcoital pregnancy-prevention drugs (i.e., the “morning-after pill,” which was denied over-the-counter status), and statins, for which a proposed status change was rejected (see Table 1 ).

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