Cholesterol drugs will come with new safety warnings

By Saundra Young, CNN

updated 4:29 PM EST, Tue February 28, 2012

FDA warns of statin side effects

STORY HIGHLIGHTS

Washington (CNN) -- An entire class of statin drugs will get new labels that alert the public to safety concerns, the Food and Drug Administration announced Tuesday.

Statins, which treat cholesterol, now will come with labels that include a warning that the drugs, taken by almost 32 million Americans, can cause memory loss and confusion. The FDA says reports in general have not been serious, and the symptoms subsided when patients stopped taking the medications.

The new labeling will also warn doctors and patients that statins can cause hyperglycemia, an increase in blood sugar levels and increase the risk of Type 2 diabetes.

The FDA will no longer recommend routine and periodic monitoring of liver enzymes of patients taking statins. Instead, it said liver enzyme tests should be performed before a patient starts taking statins, and then only when clinically indicated. That's because according to the FDA, serious injury to the liver is rare, and routine monitoring doesn't detect or prevent it. The new label will tell patients who experience fatigue, loss of appetite, dark urine, upper stomach pain or jaundice to notify their doctor immediately.

There also will be a label change specific to lovastatin (Mevacor). Certain medicines interact with this particular statin, increasing the risk of myopathy, or muscle damage. The agency says some drugs should never be taken with Mevacor including protease inhibitors, a class of HIV drugs and certain drugs used to treat bacterial and fungal infections.

"We want healthcare professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol," said Dr. Mary Parks, in the FDA's Center for Drug Evaluation and Research.

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Cholesterol drugs will come with new safety warnings