Washington, DC: The Food and Drug Administration has announced important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins. Specifically, the changes include warnings about the increased risk for type 2 diabetes mellitus. Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes.
The highly prescribed class of cholesterol-lowering drugs must also carry warnings regarding the potential for transient memory and cognitive problems. Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion.
The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).