It seems like everyone is concerned with their cholesterol levels lately — and rightfully so. Having high cholesterol could cause your arteries to become blocked and severely raise the risk of a heart attack. It is estimated that over 20 million Americans take Statins, and it is actually believed that approximately one in four Americans ages 45 and older take the cholesterol reducing medications.
Therefore, with so many Americans using the drug to reduce their cholesterol levels, I believe that it is vitally important that they also know the contraindications, as well as warnings that come along with the ever popular drug. And, the U.S. Food and Drug Administration had just issued safety announcements concerning them.
Their recent safety announcement was with updated recommendations concerning drug-drug interactions between drugs for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) and certain cholesterol-lowering drugs known as Statins.
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, or better known as the 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.
Protease inhibitors and Statins taken together 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.
The notification involved interactions between protease inhibitors and certain Statin drugs, including Lipitor (Atorvastatin), Mevacor (Lovastatin), Crestor (Rosuvastatin), and Zocor (Simvastatin).
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.
Specific information on Statin dose limitations can be accessed on the FDA’s web site.