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FDA updates safety labeling of statins

Issue: April 2012

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The FDA announced four important safety changes to the labeling for some widely used statins.

The labeling changes apply to atorvastatin (Lipitor, Pfizer), fluvastatin (Lescol, Novartis), lovastatin (Mevacor, Merck), lovastatin extended-release (Altoprev, Shinogi), lovastatin/niacin extended-release (Advicor, Abbott), pitavastatin (Livalo, Kowa Pharmaceuticals), pravastatin (Pravachol, Bristol-Myers Squibb), rosuvastatin (Crestor, Astra Zeneca), simvastatin (Zocor, Merck), simvastatin/niacin extended-release (Simcor, Abbott) and simvastatin/ezetimibe (Vytorin, Merck).

Labeling changes include:

• Removal of the need for routine periodic monitoring of liver enzymes, as serious liver injury with statins is rare and unpredictable in individual patients and routine periodic monitoring does not appear to be effective in detecting or preventing this rare side effect. The FDA now recommends that liver enzyme tests be performed before initiating statin therapy and as clinically indicated thereafter.
• Information about some patients experiencing memory loss and confusion. The agency notes that these reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, the FDA states that patients should still alert their health care professional if these symptoms occur.
• Warnings about the potential risk for hyperglycemia and being diagnosed with type 2 diabetes.
• New recommendations in the lovastatin label, noting that some medicines may interact with the drug and increase the risk for myopathy/rhabdomyolysis. For example, lovastatin should never be taken with drugs used to treat HIV (protease inhibitors) and drugs to treat certain bacterial and fungal infections.

“We want health care 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,” Mary Parks, MD, director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II at the FDA Center for Drug Evaluation and Research, said in a press release.

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