SAFETY ALERT: Safety Label Changes for Statins

The FDA has approved important safety label changes for the cholesterol-lowering drug class, known as statins.

Major changes include removal of routine monitoring of liver enzymes from drug labels and the addition of the potential for mild and reversible cognitive side effects, as well as reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels. The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.

Healthcare professionals are recommended to perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted.

Common statin products include Lipitor (atorvastatin; Pfizer), Lescol (fluvastatin; Novartis), Mevacor (lovastatin; Merck), Altoprev (lovastatin extended-release; Shionogi), Livalo (pitavastatin; Kowa), Pravachol (pravastatin; Bristol-Myers Squibb), Crestor (rosuvastatin; AstraZeneca), and Zocor (simvastatin; Merck).

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm293670.htm.