The FDA today added “important safety changes” to the labeling for some widely used statins.

These products, when used with diet and exercise, help to lower a person’s low-density lipoprotein cholesterol. The products include: atorvastatin (Lipitor, Pfizer), fluvastatin (Lescol, Novartis), lovastatin (Mevacor, Merck), lovastatin extended-release (Altoprev, Shionogi), pitavastatin (Livalo, Kowa/Eli Lilly), pravastatin (Pravachol, Bristol-Myers Squibb), rosuvastatin (Crestor, AstraZeneca) and simvastatin (Zocor, Merck). Combination products include: lovastatin/niacin extended-release (Advicor, Abbott Laboratories), simvastatin/niacin extended-release (Simcor, Abbott Laboratories) and simvastatin/ezetimibe (Vytorin, Merck/Schering-Plough Pharmaceuticals).

“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 Mary H. Parks, MD, director for the division of metabolism and endocrinology products in the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research.

The FDA put forth the following changes to statin labels:

• The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The agency now recommends 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 this rare side effect. Patients should notify their healthcare professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.
• Certain cognitive effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.
• Increases in hyperglycemia have been reported with statin use. The FDA is aware of studies showing 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 labels will now warn healthcare professionals and patients of this potential risk.
• Healthcare professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with lovastatin including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.

“The updated FDA statin label serves as an appropriate reminder to patients and physicians about the relatively rare and reversible known side effects associated with these important medications,” said American College of Cardiology’s CEO Jack Lewin, MD. “While it is important to recognize the side effects sometimes associated with statins, it is also important to emphasize that the powerful benefits of statins far outweigh the risks for the vast majority of patients.”

Reporting side effects to the FDA is important, according to the agency. Healthcare professionals and patients should report any side effects associated with statin use to FDA MedWatch program.

###

U.S. Food and Drug Administration