Vytorin and Zetia add depression to labels
Executive Summary
Depression is being added to the list of adverse reactions reported with ezetimibe use in labels for Merck/Schering Plough's Vytorin (ezetimibe/simvastatin) and Schering's Zetia (ezetimibe). Following a "changes being effected supplement" submitted by the sponsors, the Adverse Reactions section now includes information related to postmarketing experience with ezetimibe. The cholesterol-lowering drugs have been under significant political and market pressure following disclosure of results from the ENHANCE trial, showing that Vytorin failed to reduce arterial plaque better than simvastatin alone (1"The Pink Sheet," Jan. 28, 2008, p. 21)
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