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U.S. Department of Health and Human Services

Safety

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Strattera (atomoxetine hydrochloride) Capsules July 2008


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS

WARNINGS AND PRECAUTIONS

  • Suicidal Ideation
  • Effects on Blood Pressure and Heart Rate

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Initial Paragraph
    • Child and Adolescent Clinical Trials
      • Reasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trials
        • abdominal pain (0.2%, N=4)
    • Adult Clinical Trials
      • Male and female sexual dysfunction

USE IN SPECIFIC POPULATIONS

  • Patients with Concomitant Illness
    • Anxiety in patients with ADHD and comorbid Anxiety Disorders (new subsection)

MEDICATION GUIDE

  • Other information for children, teenagers, and adults...
    • ...Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BOXED WARNING

WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS

...Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior...

WARNINGS AND PRECAUTIONS

Suicidal Ideation

All pediatric patients being treated with Strattera should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

Effects on Blood Pressure and Heart Rate

Strattera-treated adult subjects experienced mean increases in systolic (about 2.0 mm Hg) and diastolic (about 1.0 mm Hg) blood pressures compared with placebo. At the final study visit before drug discontinuation, 2.2% (11/510) of Strattera-treated adult subjects had systolic blood pressure measurements >150 mm Hg compared with 1.0% (4/393) of placebo subjects. At the final study visit before drug discontinuation, 0.4% (2/510) of Strattera-treated adult subjects had diastolic blood pressure measurements >100 mm Hg compared with 0.5% (2/393) of placebo subjects. No adult subject had a high systolic or diastolic blood pressure detected on more than one occasion.