Increases in glycosylated hemoglobin (HbA1c) and fasting serum glucose levels have been reported with statin use.These reported symptoms are generally not serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use.If an alternate etiology is not found, the statin should not be restarted. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter.Patients should report side effects from the use of statins to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.Patients should contact their healthcare professional if they have any questions or concerns about statins.Certain medicines should never be taken (are contraindicated) with lovastatin (Mevacor) (see Lovastatin Dose Limitations below).Increases in blood sugar levels have been reported with statin use.These reported events were generally not serious and went away once the drug was no longer being taken. Memory loss and confusion have been reported with statin use.Patients should notify their healthcare professional right away if they have the following symptoms: unusual fatigue or weakness loss of appetite upper belly pain dark-colored urine or yellowing of the skin or the whites of the eyes. There have been rare reports of serious liver problems in patients taking statins.Patients should be aware of the following information: The statin drug labels have been revised to provide patients with more information on the safe and effective use of statins.Patients should contact their healthcare professional if they have any questions or concerns about statins. Healthcare professionals should refer to the drug labels for the latest recommendations for prescribing statins (also see Additional Information for Healthcare Professionals below). The lovastatin label has been extensively updated with new contraindications (situations when the drug should not be used) and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury (see Lovastatin Dose Limitations below). FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks. Information about the potential for generally non-serious and reversible cognitive side effects (memory loss, confusion, etc.) and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. 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. The labels now recommend that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. Infographic About Cholesterol and Statins These changes were made to provide the public with more information for the safe and effective use of statins and are based on FDA’s comprehensive review of the statin class of drugs (see Data Summary below). Food and Drug Administration (FDA) has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. Also marketed as combination products, including Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe)Īdditional Information for Healthcare Professionals.Marketed as single-ingredient products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin).A class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”).
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