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FDA Makes Label Changes to Statins

By: Mohamed Dungersi

On February 28, the U.S. Food and Drug Administration (FDA) approved important safety label changes for the class of cholesterol-lowering drugs known as statins.  Aligned with the FDA’s goal to provide the public with more information for the safe and effective use of statins, the agency made several modifications to the sections on liver enzyme monitoring, adverse events, and drug interactions.

Previously, when patients were prescribed statin medications, their liver enzymes required routine monitoring (for instance, every three months).  The FDA revised the label to remove the need for this monitoring.  The labels now recommend that prescribers should perform liver enzyme tests before starting statin therapy and “as clinically indicated thereafter.”  If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, prescribed should interrupt the therapy.  If there is no alternate etiology for these symptoms, prescribers should not restart the statin medication.

The rationale behind the abovementioned change, based on the FDA’s conclusion, is that serious liver injury with statins is rare and unpredictable in individual patients.  The routine periodic monitoring of liver enzymes did not appear to be effective in detecting or preventing serious liver injury.

The FDA also revised information about the potential for generally non-serious and reversible cognitive side effects, such as memory loss, confusion, forgetfulness, and amnesia.  It also added increased blood sugar and glycosylated hemoglobin (HbA1c) levels in the revised labels.  These reported symptoms are generally not serious, and are reversible upon statin discontinuation.  They have variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).  The FDA also states that the cardiovascular benefits of statins outweigh these small increased risks.

The third major change was to the lovastatin drug label.  The FDA updated the label with new contraindications and dose limitations.  For instance, when patients take lovastatin with certain medicines, the combination can increase the risk for myopathy/rhabdomyolysis (see following table).

Lovastatin Dose Limitations

Previous lovastatin label

New lovastatin label

Avoid lovastatin with:· Itraconazole, Ketoconazole

· Erythromycin, Clarithromycin, Telithromycin

· HIV protease inhibitors

· Nefazodone

Contraindicated with lovastatin:· Itraconazole, Ketoconazole, Posaconazole

· Erythromycin, Clarithromycin, Telithromycin

· HIV protease inhibitors

· Boceprevir, Telaprevir

· Nefazodone

Do not exceed 20 mg lovastatin daily with:· Gemfibrozil

· Other fibrates

· Lipid-lowering doses (≥1 g/day) of niacin

· Cyclosporine

· Danazol

Avoid with lovastatin:· Cyclosporine

· Gemfibrozil

Do not exceed 20 mg lovastatin daily with:· Danazol

· Diltiazem

· Verapamil

Do not exceed 40 mg lovastatin daily with:· Amiodarone

· Verapamil

Do not exceed 40 mg lovastatin daily with:· Amiodarone
Avoid large quantities of grapefruit juice (>1 quart daily) Avoid large quantities of grapefruit juice (>1 quart daily)


1. FDA. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. Website. Available online: 2012 Feb. Accessed on Feb 29, 2012.

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