Statin warnings on liver enzymes, blood glucose revised

The warning labels on statin medications are being changed, the FDA announced last week.

The recommendation for routine monitoring of liver enzymes in patients taking statins was removed. The labels now recommend that liver enzyme tests 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 serious liver injury.

Warnings will be added about the potential for generally non-serious and reversible cognitive side effects (rare cases of which have been reported) and increased blood glucose and glycosylated hemoglobin levels. However, the FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks, according to the agency's drug safety update.

Affected drugs include atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor) and simvastatin (Zocor), as well as combination products lovastatin/niacin extended-release (Advicor), simvastatin/niacin extended-release (Simcor), and simvastatin/ezetimibe (Vytorin).

The label for lovastatin has received additional updates, including new contraindications and dose limitations when it is taken with certain medications that can increase the risk for myopathy/rhabdomyolysis.