FDA Announces Safety Label Changes for Statins

February 28, 2012—The US Food and Drug Administration (FDA) announced that it has approved important safety label changes for statins. Label revisions address adverse event information, drug interactions, and liver enzyme monitoring.

First, information about the potential for generally nonserious and reversible cognitive side effects (memory loss, confusion, etc.) and reports of increased blood sugar and glycosylated hemoglobin levels have been added to the statin labels. The FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.

Second, the lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain other medications that can increase the risk for muscle injury. The lovastatin dose limitation chart outlines the various interactions and dose limitation. The agency advised that health care professionals should refer to the drug labels for the latest recommendations when prescribing statins.

Finally, labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The labels now recommend that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. The FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.

The FDA Drug Safety Communication is posted on the agency's website. It includes a summary of the data upon which the revisions are based, a chart outlining lovastatin dose limitations and drug interactions, and additional information for health care professional and patients.

According to the FDA, these changes were made to provide the public with more information for the safe and effective use of statins and are based on the FDA's comprehensive review of the statin class of drugs.

As noted by the FDA, statins are marketed as single-ingredient products and as combination products.

Single-ingredient products include Lipitor (atorvastatin, Pfizer Inc., New York, NY), Lescol (fluvastatin, Novartis Corporation, East Hanover, NJ), Mevacor (lovastatin, Merck & Co., Inc., Whitehouse Station, NJ), Altoprev (lovastatin extended-release, Schionogi Inc., Florham Park, NJ), Livalo (pitavastatin, Kowa Pharmaceuticals America, Inc., Montgomery, AL; marketed by Eli Lilly & Company, Indianapolis, IN), Pravachol (pravastatin, Bristol Myers Squibb Company, New York, NY), Crestor (rosuvastatin, AstraZeneca Pharmaceuticals LP, Wilmington, DE), and Zocor (simvastatin, Merck & Co., Inc.).

Combination products include Advicor (lovastatin/niacin extended-release, Abbott Laboratories, Abbott Park, IL), Simcor (simvastatin/niacin extended-release, Abbott Laboratories), and Vytorin (simvastatin/ezetimibe, Merck & Co., Inc.).