Label Changes for:
Emsam (selegiline transdermal system) Patches
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.|
|Sections Modified||Summary of Changes to Contraindications and Warnings|
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...
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