FDA expands on cholesterol-lowering drug risks

Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins were announced yesterday by the US Food and Drug Administration. These products, when used with diet and exercise, help to lower a person’s low-density lipoprotein cholesterol, or “bad” cholesterol.

The products include: Pfizer’s all-time best selling Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), AstraZeneca’s Crestor (rosuvastatin) and Merck & Co’s Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe). Statins are the third best selling class of drugs in the USA, where these were prescribed to nearly 21 million patients last year.

“We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” said Mary Parks, director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research.