No OTC statins
NEWS IN BRIEF — Posted Jan. 14, 2008
A Food and Drug Administration advisory committee has once again recommended the agency deny over-the-counter status to the statin drug Mevacor. The FDA generally follows the advice of its expert panels.
The advisory committee voted 10-2 on Dec. 13, 2007, against the nonprescription sale of lovastatin, which was approved in 1987 as the first of the blockbuster statin class of cholesterol-lowering medications. It's the third time a panel has rejected Merck's request for OTC status.
The AMA had opposed the OTC availability of Mevacor, noting that hypercholesterolemia is an asymptomatic disease not easily recognized and requiring a fasting lipid profile blood test to confirm the diagnosis.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2008/01/14/hlbf0114.htm.