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U.S. Department of Health and Human Services

Safety

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Vyvanse (lisdexamfetamine dimesylate) Capsules


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Prescribing and Dispensing

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Initial Section
    • Adverse Reactions Occurring at an Incidence of 2% or more Among Vyvanse Treated Patients in Clinical Trials
      • Adult
        • Table 2
        • Vital Signs
  • Adverse Reactions Associated with the Use of Amphetamine
    • Central Nervous System
      • Insomnia
    • Gastrointestinal
      • Other Gastrointestinal Disturbances
    • Allergic
      • Rashes

DRUG INTERACTIONS

  • Agents that Increase Blood Levels of Amphetamines
    • Urinary Alkalinizing Agents

USE IN SPECIFIC POPULATIONS

  • Pregnancy
    • Initial Paragraph
  • Labor and Delivery
  • Pediatric Use

PATIENT COUNSELING INFORMATION

  • Controlled Substance Status/Potential for Abuse, Misuse, and Dependence
  • Serious Cardiovascular Risks
  • Psychiatric Risks
  • Growth
  • Pregnancy
  • Nursing
  • Impairment in Ability to Operate Machinery or Vehicles

WARNINGS AND PRECAUTIONS

Prescribing and Dispensing

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Vyvanse should be used with caution in patients who use other sympathomimetic drugs.