FDA Drug Safety Podcast for Healthcare Professionals: Important safety label changes to cholesterol-lowering statin drugs
The FDA has approved important safety label changes for cholesterol-lowering statin 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 (such as memory loss and confusion) and reports of increased blood sugar and glycosylated hemoglobin 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 and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.
At this time FDA recommends Healthcare Professionals be aware that:
· Liver enzyme tests should be performed 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 (such as memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with statin use. These reporte