Take a Liver Test Before Taking Statin Drugs

Cholesterol medications under review by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) U.S. Food and Drug Administration officials have announced they will no longer recommend regular liver enzyme testing for patients taking one of several popular cholesterol-lowering drugs such as Lipitor (atorvastatin).

In addition, the label changes for the widely-used statins and combination drugs designed to lower bad LDL cholesterol will warn of potential passing memory problems and high blood sugar that could increase the risk of type 2 diabetes.

"Talk to a pharmacist about the potential side effects of statins."

Dr. Mary Parks, director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said the agency wants doctors and patients to have the most current information available concerning the risks associated with statins, while assuring them that the medications continue to offer an important cholesterol-lowering benefit.

The drugs that will feature label changes include: Lipitor, Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination medications include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).

A major label change is that patients taking statins are no longer asked to undergo routine liver enzyme testing. Instead the FDA recommends a liver enzyme test before starting statin drugs, and as a doctor deems necessary thereafter.

The reason for the change is that FDA officials have concluded that serious liver injury from the drugs is rare and unpredictable, and routine monitoring does not appear to help detect or prevent the serious side effect.

In addition, the label will be changed to note that some memory-related cognitive changes have been reported after taking statins, and information will be included about memory loss and confusion. Most cognitive side effects have been only temporary and were reversed after patients stopped taking statins.

Another label change will note that hyperglycemia, or high blood sugar, has been reported with use of statins. This could result in a small increased risk of developing type 2 diabetes, and the new labels will warn of this risk.

New recommendations also were added to the lovastatin label for health care professionals. Some drugs could interact with lovastatin and increase the risk for muscle injury.

Reviewed by: 
Review Date: 
February 28, 2012
Last Updated:
February 29, 2012