FDA Adds Diabetes Warning To Statin Label
By Peggy Peck, Executive Editor, MedPage Today // March 4, 2012
EDITOR’S NOTE: In early 2012, the FDA told pharmaceutical manufacturers of statins, a class of drugs that lowers cholesterol, to add a few new risks to the product label. These risks include memory loss, mental confusion and risk of diabetes due to higher blood sugar. However, experts agree that the benefits of statins in preventing and treating atherosclerosis that causes chest pain, heart attacks, strokes, and intermittent claudication in individuals who have or are at risk for atherosclerosis far outweighs these new risks.
WASHINGTON, DC — The FDA said today that all statins must carry warnings about increased risks of elevated blood sugar and possible transient memory and cognition problems, but at the same time the agency removed a standing recommendation for routine liver function tests for patients taking the cholesterol-lowering drugs.
The FDA said the label changes apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor).
Despite the additional warnings, the FDA said it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”
CLICK HERE to read the complete story on MedPageToday.com.