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FDA Drug Safety Podcast for Healthcare Professionals: Important safety label changes to cholesterol-lowering statin drugs

Listen to This Podcast

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Important safety label changes to cholesterol-lowering statin drugs.

CDR Catherine Chew, a US Public Health Service pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: The FDA has approved important safety label changes for cholesterol-lowering statin drugs. 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 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 (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.

Drug Interactions

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 reported symptoms are generally not serious and reversible upon statin discontinuation with variable times to symptom onset (between a day to years) and symptom resolution with a median of 3 weeks.
  • Increases in glycosylated hemoglobin and fasting serum glucose levels have been reported with statin use.
  • Recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin should be followed.
  • Adverse events involving statins should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  A link to this communication, including the complete Data Summary and lovastatin dose limitations can be found at www.fda.gov/DrugSafetyCommunications.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 


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