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Amphetamine, Dextroamphetamine, Lisdexamfetamine dismesylate, Methamphetamine, Mixed Salts of Single Entity Amphetamine Products

High Abuse/Diversion potential

  • Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.

Drug dependence

  • Administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided.

Serious Adverse Events

  • Misuse of amphetamines may cause sudden death and serious cardiovascular adverse event

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

Black Box Revision: August 2006

 

FDA and Industry Communications

  • New Drug Approval with Black Box: Lisdexamfetamine dimesylate (February 2007)
  • FDA News Release Regarding Attention-Deficit Hyperactivity Disorder (ADHD) and Patient Notification of Psychiatric and Cardiac Adverse Events(February 2007)
  • FDA Asks Attention-Deficit Hyperactivity Disorder (ADHD) Drug Manufacturers to Develop Patient Medication
  • FDA Medication Guide

    • Patient Counseling Information

    • ADDERALL
    • DESOXYN
    • DEXEDRINE

    Medication Guides

    Patient Medication Guide

    Package Inserts

    Amphetamines

    Updated June 2009