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U.S. Department of Health and Human Services

Safety

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Strattera (atomoxetine hydrochloride) Capsules


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

WARNINGS AND PRECAUTIONS

  • Effects on Blood Pressure and Heart Rate
  • Effects on Urine Outflow from the Bladder
  • Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients who are known to be CYP2D6 PMs

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Initial Section
  • Child and Adolescent Clinical Trials
    • Reasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trials
    • Commonly observed adverse reactions in acute child and adolescent, placebo-controlled trials
      • Table 1
      • Table 2
      • The following adverse reactions occurred in at least 2%...
  • Adult Clinical Trials
    • Reasons for discontinuation of treatment due to adverse reactions in acute adult placebo-controlled trials
    • Commonly observed adverse reactions in acute adult placebo-controlled trials
      • Table 3
  • Postmarketing Spontaneous Reports
    • Urogenital System
      • Male Pelvic Pain

WARNINGS AND PRECAUTIONS

Effects on Blood Pressure and Heart Rate

See highlighted text for revised labeling.

Effects on Urine Outflow from the Bladder

In adult ADHD controlled trials, the rates of urinary retention (1.7%, 9/540) and urinary hesitation (5.6%, 30/540) were increased among atomoxetine subjects compared with placebo subjects (0%, 0/402 ; 0.5%, 2/402, respectively)...

Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients who are known to be CYP2D6 PMs

Atomoxetine is primarily metabolized by the CYP2D6 pathway to 4-hydroxyatomoxetine. Dosage adjustment of Strattera may be necessary when coadministered with potent CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine) or when administered to CYP2D6 PMs...

 

Label approved 05/07/2008 is not available on Drugs@FDA

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