Zocor

Simvastatin

For High Cholesterol

Track record

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Long (approved in 1991)

Bottom line

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High Cholesterol

What is High Cholesterol?

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Other treatments for High Cholesterol

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

FDA-approved use

To lower cholesterol to reduce the chance of death, having or dying from a first heart attack or having a stroke in adults at increased risk

Zocor is a statin. All major medical organizations suggest considering drugs in the statin family - not just Zocor- to reduce the chance of a first heart attack or stroke in adults at increased risk. FDA officially approved Zocor to reduce the chance of having or dying from a heart attack, having a stroke and having procedures to unblock arteries in heart or legs in people with diabetes and high cholesterol without heart disease or a stroke. FDA also approved Zocor to lower LDL "bad" cholesterol, raise HDL "good" cholesterol, and lower triglycerides in adults and children 10 years and older with abnormal cholesterol levels from a genetic condition.

Who might consider taking it?

Adults without heart disease or a stroke but at increased risk

The American Heart Association suggests people consider a statin if their chance of heart attack or stroke over the next 10 years is more than 5%, and to take one if the chance is 7.5% or more. You can calculate your risk at: http://tinyurl.com/pyv57ne.

What is not known

Not known if severe muscle breakdown (rhabdomyolsyis) is more likely in people of Chinese descent who take Zocor + Niacin than in people of other Asian descent

Not studied in children younger than age 10 or in girls who have not started their period

Not studied in people with Fredrickson Types I and V dyslipidemias

Track record

LONG TRACK RECORD

Long track record means that new‚ unexpected side effects are unlikely. Zocor was approved by FDA in 1991. Since Zocor has now been used by large numbers of people over a long time‚ the emergence of important side effects is less likely than with new drugs.

Open questions

No FDA-required studies at approval

Do not take if you...

Take medicines in the family called "strong CYP3A4 inhibitors"

Certain anti-fungal medicines (such as itraconazole, ketoconazole, posaconazole, or voriconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, or atazanavir), certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir), certain antibiotics (such as erythromycin, clarithromycin, or telithromycin), nefazodone, and medicines containing cobicistat

Take cyclosporine, gemfibrozil, or danazol

Are allergic to Zocor or its ingredients

Have liver disease

Including people who have unexplained high liver inflammation blood tests

Are pregnant or may become pregnant

Zocor may harm your unborn baby. If you become pregnant, stop taking Zocor

Are breastfeeding

Safe if pregnant or breastfeeding?

Pregnant

Do not take: Controlled human studies show Zocor harms baby and potential benefits do not outweigh potential harms (FDA Category X)

Breastfeeding

Do not breastfeed while taking Zocor - either stop breastfeeding or stop Zocor

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