FDA Warns Of Statin Interactions With HIV, Hepatitis C Drugs

The U.S. Food and Drug Administration (FDA) issued a warning concerning statin interactions with HIV and hepatitis C medications. The notification involved interactions between protease inhibitors and certain statin drugs, including Lipitor (Atorvastatin), Mevacor (Lovastatin), Crestor (Rosuvastatin), and Zocor (Simvastatin).

It seems that when protease inhibitors and cetain statins are taken together, they may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

Statins are a class of prescription drugs that are used in combination with diet and exercise to lower the blood levels of low-density lipoprotein (LDL) cholesterol—so-called bad cholesterol. HIV protease inhibitors are a class of prescription anti-viral drugs prescribed for the treatment of HIV. HCV protease inhibitors are a class of prescription anti-viral drugs that treat hepatitis C infection.

Increased cholesterol and triglyceride (fat) levels are side effects of HIV protease inhibitors; therefore, some patients taking HIV protease inhibitors may also need to take cholesterol-lowering medicines, such as statins.

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

The agency advises that healthcare professionals should follow the recommendations in the prescribing information/drug labels when prescribing HIV or HCV protease inhibitors with statins.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online or download the reporting form or call, toll-free, at 1.800.332.1088 to request a reporting form. Complete and return the form to the address on the pre-addressed form, or submit the form, by toll-free fax, to 1.800.FDA.0178.

Specific information on statin dose limitations can be accessed on the FDA’s web site. h

This entry was posted in Crestor, Pharmaceuticals, Zocor. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.