FDA Adds Diabetes & Memory Loss Warnings To Statins

Widely used cholesterol-lowering statin drugs like Lipitor (atorvastatin), Crestor (rosuvastatin), Zocor (simvastatin), Simcor (simvastatin/niacin extended-release), Vytorin (simvastatin/ezetimibe) and many others will now have additional warnings on their packaging, according to an announcement from the Food & Drug Administration.

The labels will now have to reflect that some statin users have reported experiencing memory loss and confusion. FDA says the reports “generally have not been serious and the patients’ symptoms were reversed by stopping the statin,” but that patients should still tell their doctor if it happens.

Additionally, the labels will indicate that there is a small risk for increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus.

On the plus side, the labels will no longer state a need for routine periodic monitoring of liver enzymes in statin users.

“FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients,” writes the agency, “and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect.”