Label Changes for:

Emsam (selegiline transdermal system) Patches

February 2008

Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.


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

  • Suicidality and Antidepressant Drugs

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Pediatric Use
    • Due to limited data, Emsam at any dose should not be used in children under the age of 12 years even when administered with dietary modifications. Emsam is not approved for use in pediatric patients.
    • Commercially available doses of Emsam have not been studied in children under the age of 12 years. Limited pharmacokinetic data with lower doses than in the commercially available formulations suggest that children under the age of 12 years treated with Emsam may be exposed to increased levels of selegiline compared to adolescents or adults. Therefore, the possibility exists for an increased risk of hypertensive crisis, even at the lowest dose of
      commercially available Emsam, when administered without dietary modifications.

MEDICATION GUIDE

  • Emsam at any dose should not be used in children under the age of 12 years even when administered with dietary modifications. Emsam is not approved for use in pediatric patients.

BOXED WARNING

Suicidality and Antidepressant Drugs

...Furthermore, Emsam at any dose should not be used in children under the age of 12, even when administered with dietary modifications...

WARNINGS

Clinical Worsening and Suicide Risk

Due to the limited data, Emsam at any dose should not be used in children uder the age of 12 years even when administered with dietary modifications. Emsam is not approved for use in pediatric patients...

Label approved 02/13/2008 is not available on Drugs@FDA

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