Label Changes for:

Singulair (montelukast sodium) tablets, chewable tablets and oral granules

August 2009

Changes have been made to the PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

PRECAUTIONS

  • Neuropsychiatric Events subsection was added
    • Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking Singulair. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities...
Information for Patients
  • A statement advising patients to notify their physician if neuropsychiatric events occur while using Singulair was added

ADVERSE REACTIONS

Post-Marketing Experience
  • hostility
  • somnambulism

SUPPLEMENTAL PATIENT MATERIAL now titled PATIENT PACKAGE INSERT

  • addition of a statement instructing patients to inform their physicians of neuropsychiatric events
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