Food and Drug Administration relabels some cholesterol-lowering drugs on safety risks involving memory loss and diabetes

The U.S. Food and Drug Administration has changed the label on a group of statin drugs commonly used to lower bad cholesterol.  Added to the the labels of these drugs is information that some patients have experienced memory loss and confusion. The effects were not considered serious and the patients’ symptoms were reversed by stopping the statin, the new label says. However, patients should still alert their health care professional if these symptoms occur. 

The drugs involved in the label change 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).
Another potential risk added to the label involves blood glucose levels.  Increases in blood sugar levels (hyperglycemia) have been reported with statin use, according to the FDA announcement. The agency notes that some studies have reported 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 mellitus". The new labels warn healthcare professionals and patients of this potential risk.

For those of you taking cholesterol drugs and receiving routine blood tests four times a year to monitor for liver function, you should be aware of a label change in that area as well, removing the need for periodic exams.  The FDA now recommends that liver enzyme tests should be performed before  a patient starts statin therapy, and then only as clinically indicated thereafter. FDA said  in its press release on the changes 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 this rare side effect.

If you are taking Mevachor (lovastatin), you should note that the label will now warn that Mevachor can interact with some drugs to increase the risk of muscle injury and recommends against taking the drug with drugs used to treat HIV (protease inhibitors) and those used to treat certain bacterial and fungal infections.

What you can do:
If you have symptoms of muscle weakness, memory loss, or suspected high blood sugar, contact your physician and report confirmed side effects to FDA's Medwatch system.  If you know you are pre-diabetic, you may want to ask your doctor to continue periodic exams to be sure your blood sugar is not pushed up into the diabetes range.