Adderall XR

Mixed salts of a single-entity amphetamine product

For ADHD

Track record

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Long (approved in 2001)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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ADHD

What is ADHD?

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It’s normal for children to have difficulty paying attention and controlling their behavior at times. What should lead you to suspect ADHD is a persistent pattern lasting at least six months of abnormally high levels of physical activity (hyperactivity), impulsivity, and/or lack of ability to pay attention and focus or complete tasks.

Other treatments for ADHD

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

FDA-approved use

To reduce the symptoms of attention deficit hyperactivity disorder (ADHD)

If Adderall XR is used it should be part of a total treatment program for ADHD that may include counseling or other therapies

Who might consider taking it?

Adults, adolescents, and children with ADHD

What is not known

Adderall XR is not meant for use in the those with ADHD due to environmental factors and/or other psychiatric disorders, including psychosis

Benefits and side effects have not been studied in children less than 6 years old

Effectiveness of Adderall XR for long term use (more than 3 weeks in children and 4 weeks in adolescents and adults) has not been systematically evaluated in controlled trials

Track record

LONG TRACK RECORD

Long track record means that new‚ unexpected side effects are unlikely. Amphetamine mixed salts in Adderall were approved by FDA in 1960 but the extended release form - Adderall XR - was approved in 2001. Since the extended release form of Adderall has now been used by large numbers of people over a longer time‚ the emergence of rare but serious side effects is less likely than with a new drug.

Open questions

No FDA-required studies at approval

Do not take if you...

Have heart disease

Heart attack in past or symptoms of heart disease like chest pain with exertion (angina) or are known to have blockages in heart arteries (atherosclerosis)

Have moderate to severe high blood pressure

Have hyperthyroidism

Are allergic to Adderall XR or other drugs called sympathomimetic amines

Severe allergic reactions include hives, swelling of face, lips, tongue, throat, or trouble breathing or swallowing (anaphylaxis), or serious skin rashes, total body swelling

Have glaucoma

Are very anxious, tense or agitated

Have a drug abuse history

Take a depression medicine called a monoamine oxidase inhibitor (MAOI)

Don't take Adderall XR if you have taken a MAOI within the past 14 days

Safe if pregnant or breastfeeding?

Pregnant

Only take if potential benefits outweigh potential harm to baby (FDA Category C)

Breastfeeding

Not recommended - Adderall XR gets into breast milk

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