April 2012 Drug Information Update - Pharmacy Benefits ...

Statin Drugs - Drug Safety Communication: Class Labeling Change
[Posted 2/28/2012]
ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs
known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels.
Information about the potential for generally non-serious and reversible cognitive side effects and reports
of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels.
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.
BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce
blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). Marketed as singleingredient
products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev
(lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and
Zocor (simvastatin). Also marketed as combination products, including Advicor (lovastatin/niacin
extended-release), Simcor (simvastatin/niacin extended-release),and Vytorin (simvastatin/ezetimibe).
RECOMMENDATION: Healthcare professionals should perform liver enzyme tests 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.
Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that
may increase the risk of myopathy/rhabdomyolysis when used with lovastatin.
Article
link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/uc
m293670.htm
Source website: http://www.fda.gov/default.htm
Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction
Increases Risk of Muscle Injury
[Posted 03/01/2012]
ISSUE: FDA notified healthcare professionals of updates to the prescribing information concerning
interactions between protease inhibitors and certain statin drugs. 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.
BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce
blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). HIV protease inhibitors are
a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of
prescription anti-viral drugs used to treat hepatitis C infection.
RECOMMENDATION: Healthcare professionals should follow the recommendations in the prescribing
information ( drug labels ) when prescribing HIV or HCV protease inhibitors with statins. See the FDA
Drug Safety Communication for additional information, including a data summary.
Article
link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/uc
m294294.htm
Source website: http://www.fda.gov/default.htm
The MedWatch February 2012 Safety Labeling Changes posting includes 65 products
with safety labeling changes to the following sections: BOXED WARNINGS,
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and
PATIENT PACKAGE INSERT.
[Posted 03/15/2012]
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm294217.htm
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