ACC/AHA/NHLBI Clinical Advisory on the Use and Safety of Statins

Abstract

The voluntary withdrawal of cerivastatin (Baycol) from the U.S. market on August 8, 2001, by the manufacturer, in agreement with the Food and Drug Administration (FDA), has prompted concern on the part of physicians and patients regarding the safety of the cholesterol-lowering class of drugs called HMG CoA reductase inhibitors, more commonly known as “statins.” This American College of Cardiology/American Heart Association/National Heart, Lung and Blood Institute (ACC/AHA/NHLBI) Clinical Advisory is intended to summarize for professionals the current understanding of statin use, focused on myopathy, and to provide updated recommendations for the appropriate use of statins, including cautions, contraindications, and safety monitoring for statin therapy. Its purpose is not to discourage the appropriate use of statins, which have life-saving potential in properly selected patients, particularly those with established coronary heart disease (CHD) and others at high risk for developing CHD. Included are recent myopathy information compiled by the FDA, information from clinical trials, and summaries from the recently released report of the Adult Treatment Panel III (ATP III) of the National Cholesterol Education Program (NCEP).1