FDA black box warning on the use of 80 mg simvastatin
Template:Hypercholesterolemia
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-632-7753; Associate Editor(s)-In-Chief: Kashish Goel, M.D.
Overview
Simvastatin 80 mg is the highest approved dose for this drug and it is estimated that approximately 2.1 million patients in the U.S. were prescribes this dose in the year 2010<ref>http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm<ref>. Based on the review of randomized clinical trial, Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), FDA recommended limiting the use of high-dose simvastatin.