Today, the U.S. Food and Drug Administration is set to decide whether or not to approve Merck's bid to sell un-prescribed over-the-counter cholesterol medication. This is Merck's third attempt at getting the U.S. to approve the OTC sale of Mevacor, a statin.
The decision could mark a major shift in what types of drugs are approved for OTC sale because, unlike most nonprescription drugs, statins often require long-term use and high cholesterol cannot be easily self diagnosed.
The FDA is relying on an advisory panel to determine whether or not patients can decide for themselves if they should be using nonprescription statin. It will then be up to the FDA to make the final decision, though they usually follow the guidance of the expert advisory panel.
Interestingly, a new government report about American cholesterol levels is getting a lot of press. According to a report released on Wednesday, this is the first time in 50 years that American cholesterol levels are within normal range! Don't get too excited; the report, which gathered data through a national survey, states that total cholesterol levels dropped to 199. Most doctors want their patients to have total cholesterol levels below 200. The study authors (the Center for Disease Control was the lead author) attribute the decline in cholesterol to the wide use of cholesterol lowering medication, especially by the 60 and over age group.
What do you think? Would you take an over-the-counter statin? Do you think patients are capable of deciding whether or not they need to be on statin?
Published On: December 13, 2007