Pravachol

Pravastatin

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 having or dying from a first heart attack or stroke in adults at increased risk.

Pravachol is a statin. All major medical organizations suggest considering drugs in the statin family - not just Pravachol - to reduce the chance of a first heart attack or stroke in adults at increased risk. FDA officially approved Pravachol to reduce the chance of dying from heart attacks or strokes, having a heart attack and having procedures to unblock arteries in heart or legs in people with high cholesterol without heart disease or a stroke. FDA also approved Pravachol to lower LDL "bad" cholesterol, raise HDL "good" cholesterol, and lower triglycerides in adults and children 8 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 tested in children with younger than age 8

Doses higher than 40mg not tested in children age 8 to 18

Not tested in people with Fredrickson Type I and V dyslipidemias

Track record

LONG TRACK RECORD

Long track record means that new‚ unexpected side effects are unlikely. Pravachol was approved by FDA in 1991 to lower cholesterol and was approved for prevention of heart attack or stroke in 1996. Since Pravachol 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

Cannot tell if FDA required studies at approval because document not available

Do not take if you...

Are allergic to Pravachol or its ingredients

Have liver disease

Including people who have unexplained high liver inflammation blood tests

Are pregnant or may become pregnant

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

Are breastfeeding

Safe if pregnant or breastfeeding?

Pregnant

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

Breastfeeding

Do not breastfeed - Pravachol gets into breast milk and may harm baby

NEXT: TRIALS

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