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FDA Issues New Label Requirements for Statins

Pills in a prescription bottle (


The Food and Drug Administration has issued new labeling regulations for statins, a class of drugs used to lower cholesterol levels. When taken in combination with changes in diet and exercise, statins can can reduce levels of low-density lipoprotein (LDL or “bad”) cholesterol in the blood.

LDL cholesterol circulating in the blood can deposit on the walls of arteries, leading to a build-up of a cholesterol and white blood cells, as well as inflammation, which over time can block the artery, a condition called atherosclerosis. Statins lower the level of cholesterol in the blood by reducing the production of cholesterol, by blocking the enzyme in the liver responsible for making cholesterol.

The new statin labeling requirements add warnings based on new reports and findings on cognitive effects and blood sugar levels. While the cognitive side effects are not considered serious and can be reversed, labels will still be required to inform readers of reports about memory loss and confusion when taking statins. FDA likewise requires label warnings that people taking statins run a small risk of hyperglycemia or increased sugar levels, which can lead to type 2 diabetes.

New statin labels will remove requirements for routine periodic monitoring of liver enzymes in patients taking statins. FDA now concludes that serious liver injury with statins occurs rarely, and that routine periodic monitoring of liver enzymes does not appear to detect or prevent this rare side effect. The agency recommends that liver enzyme tests be performed before starting statin therapy, and later if clinically needed.

The new requirements apply to the single use statins Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin).  New labels will also be required on the combination statins Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).

FDA has issued a separate alert for health professionals about the drug lovastatin, marketed as Mevacor by Merck. The warning includes additional drugs that may interact with lovastatin and other compounds that should not be taken with the drug, such as protease inhibitors to treat HIV and certain drugs to bacterial and fungal infections.

Read more: FDA Approves Anti-Clotting Drug for Stroke Prevention

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