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Health Highlights: Jan. 21, 2008
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FDA Review: Sale of OTC Cholesterol Drug Poses Risks
Is it three strikes and you're out for over-the-counter (OTC) sales of the cholesterol-lowering drug Mevacor?
Twice before, the drug's maker, Merck & Co., has asked the U.S. Food and Drug Administration to approve it for OTC sales. The most recent was just last month, and an FDA advisory panel overwhelmingly recommended against approval.
Now, theAssociated Pressreported, an FDA review released last week still has major doubts. Positive news for Merck was that the staff reviewer found that nonprescription Mevacor would be "a reasonably safe and effective" option, the wire service reported -- if consumers used it as directed.
And that presents a big problem, theAPreported. An FDA review of a Merck-conducted consumer survey found there was too much confusion as to who should be taking Mevacor and for what reason.
The FDA conclusion: The survey results "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," according to theAP.
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