Drugs

FDA Drug Safety Podcast for Healthcare Professionals: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Interactions between certain HIV or HCV drugs and statins can increase the risk of muscle injury.

Lindsay Davison, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: The Food and Drug Administration is issuing updated recommendations concerning drug-drug interactions between HIV or HCV drugs known as protease inhibitors and certain cholesterol-lowering drugs known as statins. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (or myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

The labels for both the HIV protease inhibitors and the affected statins have been updated to contain consistent information about the drug-drug interactions. These labels also have been updated to include dosing recommendations for those statins that may safely be co-administered with HIV or HCV protease inhibitors.

Healthcare professionals should refer to the current drug labels for protease inhibitors and statins for the latest recommendations on prescribing these drugs.

At this time FDA recommends Healthcare Professionals be aware of the following:

Co-administration of HIV or HCV protease inhibitors with certain statins can increase the risk of myopathy or rhabdomyolysis.
When prescribing HIV or HCV protease inhibitors with statins, recommendations in the drug labels should be followed.
Adverse events involving HIV or HCV protease inhibitors or 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 statin dose limitations can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.