In a recent Safety Announcement, the U.S. Food and Drug Administration (FDA) announced that it approved important safety label changes for the class of cholesterol-lowering drugs known as 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.
The changes include the following:
Monitoring Liver Enzymes
Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The labels now recommend that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. 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.
Adverse Event Information
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 continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.
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.
The FDA recommends that healthcare professionals refer to the drug labels for the latest recommendations for prescribing statins. Patients should contact their healthcare professional if they have any questions or concerns about statins.
The FDA provides the following information for patients:
- The statin drug labels have been revised to provide patients with more information on the safe and effective use of statins. Patients should be aware of the following information:
- There have been rare reports of serious liver problems in patients taking statins. 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.
- Memory loss and confusion have been reported with statin use. These reported events were generally not serious and went away once the drug was no longer being taken.
- Increases in blood sugar levels have been reported with statin use.
- Certain medicines should never be taken (are contraindicated) with lovastatin (Mevacor).
- Patients should contact their healthcare professional if they have any questions or concerns about statins.
- Patients should report side effects from the use of statins to the FDA MedWatch program.
The FDA provides the following information for healthcare professionals:
- Healthcare professionals should 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. If an alternate etiology is not found, the statin should not be restarted.
- There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated 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).
- Increases in glycosylated hemoglobin (HbA1c) and fasting serum glucose levels have been reported with statin use.
- Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin.
- Healthcare professionals should report adverse events involving statins to the FDA MedWatch program.