Lescol

Fluvastatin

For High Cholesterol

Track record

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Long (approved in 1993)

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 slow the buildup of cholesterol in arteries and reduce the need for procedures to unclog arteries in adults with heart disease

Lescol has NOT been shown to prevent heart attacks or stroke. FDA also approved Lescol 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 with high cholesterol and heart disease

What is not known

Not studied in people with Fredrickson Types I, III, IV, or V dyslipidemias

Not studied in children younger than age 9

Not tested for longer than 2 years in children younger than age 18 with high cholesterol. Long-term benefits of taking Lescol in childhood are not known.

Track record

Long track record means that new‚ unexpected side effects are unlikely

Lescol was originally approved by FDA in 1993 for high cholesterol and approved for prevention of heart revascular procedures in 2003. Since Lescol 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...

Are allergic to Lescol or its ingredients

Have liver disease

Including people who have unexplained high liver inflammation blood tests

Are pregnant or may become pregnant

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

Are breastfeeding

Take gemfibrozil

Safe if pregnant or breastfeeding?

Pregnant

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

Breastfeeding

Do not breastfeed - Lescol gets into breast milk and can harm baby

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