Label Changes for:
Singulair (montelukast sodium) tablets, chewable tablets and oral granules
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
- 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
SUPPLEMENTAL PATIENT MATERIAL now titled PATIENT PACKAGE INSERT
- addition of a statement instructing patients to inform their physicians of neuropsychiatric events