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U.S. Department of Health and Human Services

Safety

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

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

 

Summary View

 

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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